FDA Product Code
FDA Product Code MHX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1025
510(k) Clearances — 430 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M | GE Healthcare Finland Oy | 2026-09-01 | Traditional | PDF ↗ |
| K260343 | Carescape Canvas 1000; Carescape Canvas Smart Display | GE Healthcare Finland Oy | 2026-08-28 | Traditional | PDF ↗ |
| K260579 | Infinity® Acute Care System (IACS) VG8.1 | Draeger Medical Systems, Inc. | 2026-08-20 | Traditional | PDF ↗ |
| K251508 | Telemetry Monitor (iT30, iT50) | Edan Instruments, Inc. | 2026-08-06 | Traditional | PDF ↗ |
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2026-07-24 | Traditional | PDF ↗ |
| K254209 | Radius VSM and Accessories | Masimo Corporation | 2026-06-04 | Traditional | PDF ↗ |
| K252840 | M12 Telemetry System | Global Instrumentation, LLC | 2026-05-29 | Traditional | PDF ↗ |
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-05-20 | Traditional | PDF ↗ |
| K250349 | Vista CMS | Shanghai Draeger Medical Instrument Co., Ltd. | 2026-04-24 | Traditional | PDF ↗ |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-04-16 | Traditional | PDF ↗ |
| K252250 | Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) | Shanghai Draeger Medical Instrument Co., Ltd. | 2026-04-10 | Traditional | PDF ↗ |
| K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) | Philips Medizin Systeme Boeblingen GmbH | 2026-02-06 | Traditional | PDF ↗ |
| K252589 | Corvair Monza | AliveCor, Inc. | 2026-01-09 | Traditional | PDF ↗ |
| K250854 | Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro) | Shenzhen Comen Medical Instruments Co.,Ltd | 2025-12-17 | Traditional | PDF ↗ |
| K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) | Philips Medizin Systeme Böblingen GmbH | 2025-11-10 | Traditional | PDF ↗ |
| K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | Philips Medizin Systeme Boeblingen GmbH | 2025-10-17 | Traditional | PDF ↗ |
| K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) | Philips Medizin Systeme Böblingen GmbH | 2025-09-02 | Traditional | PDF ↗ |
| K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Edan Instruments, Inc. | 2025-07-29 | Traditional | PDF ↗ |
| K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2025-07-09 | Traditional | PDF ↗ |
| K250757 | Radius VSM and Accessories | Masimo Corporation | 2025-05-29 | Traditional | PDF ↗ |
| K242962 | Telemetry Monitor 5500 Release 4.0 (867232) | Philips Medizin Systeme Böblingen GmbH | 2025-05-05 | Traditional | PDF ↗ |
| K240312 | Infinity CentralStation Wide | Draeger Medical Systems, Inc. | 2024-08-01 | Traditional | PDF ↗ |
| K240320 | Patient Monitor (RespArray) | Edan Instruments, Inc. | 2024-06-28 | Traditional | PDF ↗ |
| K231010 | Corvair | AliveCor, Inc. | 2024-06-07 | Traditional | PDF ↗ |
| K232962 | Patient Monitor (iX10, iX12, iX15) | Edan Instruments, Inc. | 2024-04-19 | Traditional | PDF ↗ |
| K232694 | Central Monitoring System (MFM-CMS) | Edan Instruments, Inc. | 2024-02-05 | Traditional | PDF ↗ |
| K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468) | Philips Medizin Systeme Boeblingen GmbH | 2023-12-19 | Traditional | PDF ↗ |
| K230604 | IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) | Philips Medizin Systeme Boeblingen GmbH | 2023-11-22 | Traditional | PDF ↗ |
| K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+ | Draeger Medical Systems, Inc. | 2023-10-17 | Traditional | PDF ↗ |
| K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066) | Philips Medizin Systeme Boeblingen GmbH | 2023-08-22 | Traditional | PDF ↗ |
| K221056 | ARGUS PB-3000 | Schiller AG | 2023-07-06 | Traditional | PDF ↗ |
| K223498 | Radius VSM and Accessories | Masimo Corporation | 2023-06-01 | Traditional | PDF ↗ |
| K223531 | CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) | GE Healthcare Finland Oy | 2023-04-06 | Traditional | PDF ↗ |
| K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) | Philips Medizin Systeme Böblingen GmbH | 2023-02-03 | Traditional | PDF ↗ |
| K211619 | Multi-Parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2022-12-29 | Traditional | PDF ↗ |
| K222586 | Mural Clinical Viewer | Ge Medical Systems Information Technologies, Inc. | 2022-12-21 | Traditional | PDF ↗ |
| K221904 | EK12 V2 Algorithm | Ge Medical Systems Information Technologies, Inc. | 2022-12-20 | Traditional | PDF ↗ |
| K220308 | Patient Monitor: RespArray | Edan Instruments, Inc. | 2022-08-11 | Traditional | PDF ↗ |
| K221879 | Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 | Caf Medical Solutions, Inc. | 2022-08-10 | Traditional | PDF ↗ |
| K221616 | Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 | Caf Medical Solutions, Inc. | 2022-08-01 | Traditional | PDF ↗ |
| K220989 | Next Generation NetKonnect | Nihon Kohden Digital Health Solutions, Inc. | 2022-07-29 | Special | PDF ↗ |
| K213799 | N Series Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-07-12 | Traditional | PDF ↗ |
| K213181 | CARESCAPE B650, E-musb | GE Healthcare Finland Oy | 2022-04-13 | Traditional | PDF ↗ |
| K213336 | Carescape B850, E-musb | GE Healthcare Finland Oy | 2022-04-13 | Traditional | PDF ↗ |
| K213363 | CARESCAPE B450, E-musb | GE Healthcare Finland Oy | 2022-04-13 | Traditional | PDF ↗ |
| K213234 | CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201 | Ge Medical Systems Information Technologies, Inc. | 2022-04-12 | Traditional | PDF ↗ |
| K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2022-04-01 | Traditional | PDF ↗ |
| K211900 | Patient Information Center iX | Philips Medizin Systeme Böblingen GmbH | 2022-03-04 | Traditional | PDF ↗ |
| K203088 | Infinity Acute Care System (IACS) Monitoring System | Draeger Medical Systems, Inc. | 2022-02-01 | Traditional | PDF ↗ |
| K201764 | Infinity Acute Care System (IACS) Monitoring Solution | Draeger Medical Systems, Inc. | 2021-12-09 | Traditional | PDF ↗ |
| K210906 | IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4 | Philips Medizin Systeme Boeblingen GmbH | 2021-10-07 | Traditional | PDF ↗ |
| K203435 | Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System | Nihon Kohden Corporation | 2021-07-16 | Traditional | PDF ↗ |
| K202336 | Patient Monitor | Edan Instruments, Inc. | 2021-01-23 | Traditional | PDF ↗ |
| K202405 | BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-01-07 | Traditional | PDF ↗ |
| K201941 | Monitor B125, Monitor B105 | Ge Medical Systems Information Technologies, Inc. | 2020-11-04 | Traditional | PDF ↗ |
| K201746 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies Limited | 2020-09-18 | Special | PDF ↗ |
| K192137 | IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 | Philips Medizin Systeme Boeblingen GmbH | 2020-09-11 | Abbreviated | PDF ↗ |
| K200859 | Infinity M300 | Draeger Medical Systems, Inc. | 2020-08-28 | Traditional | PDF ↗ |
| K200015 | ePM Series Patient monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-06-08 | Traditional | PDF ↗ |
| K192972 | Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-07 | Traditional | PDF ↗ |
| K192514 | Patient Monitor | Edan Instruments, Inc. | 2020-04-02 | Traditional | PDF ↗ |
| K200494 | CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES | GE Healthcare | 2020-03-29 | Special | PDF ↗ |
| K191323 | Carescape B850 | GE Healthcare Finland Oy | 2020-01-29 | Traditional | PDF ↗ |
| K191249 | CARESCAPE B450 | GE Healthcare Finland Oy | 2020-01-24 | Traditional | PDF ↗ |
| K191149 | CARESCAPE B650 | GE Healthcare Finland Oy | 2020-01-21 | Traditional | PDF ↗ |
| K190008 | Carescape One | GE Healthcare | 2019-12-20 | Traditional | PDF ↗ |
| K190939 | ZOLL Arrhythmia Management Sysyem | Zoll Manufacturing Corporation | 2019-12-19 | Traditional | PDF ↗ |
| K191106 | C50 and C80 Multi-parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2019-12-13 | Traditional | PDF ↗ |
| K182979 | IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 | Philips Medizin Systeme Boeblingen GmbH | 2019-11-19 | Special | PDF ↗ |
| K191769 | ePM Series Patient monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-10-31 | Traditional | PDF ↗ |
| K183387 | M3290B Patient Information Center iX | Philips Medical Systems | 2019-08-06 | Traditional | PDF ↗ |
| K190011 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-07-10 | Traditional | PDF ↗ |
| K173036 | North-vision Multi-parameter Patient Monitor | North-Vision Tech., Inc. | 2018-12-21 | Traditional | PDF ↗ |
| K182075 | BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-12-10 | Traditional | PDF ↗ |
| K180482 | ZOLL Propaq M | ZOLL Medical Corporation | 2018-11-30 | Traditional | PDF ↗ |
| K181831 | IntelliVue Multi-Measurement Module MMX | Philips Medizin Systeme Boeblingen GmbH | 2018-11-15 | Abbreviated | PDF ↗ |
| K173765 | Surveyor Patient Monitor | Mortara Instrument, Inc. | 2018-09-04 | Traditional | PDF ↗ |
| K181314 | IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension | Philips Medizin Systeme Boeblingen GmbH | 2018-09-04 | Traditional | PDF ↗ |
| K173454 | Multi-parameter Patient Monitor, models C30 | Shenzhen Comen Medical Instruments Co.,Ltd | 2018-08-16 | Traditional | PDF ↗ |
| K180017 | MX40 Release C.01 | Philips Medical Systems | 2018-07-24 | Special | PDF ↗ |
| K180472 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | 2018-06-19 | Traditional | PDF ↗ |
| K172510 | µCor Heart Failure and Arrhythmia Management System | Zoll Manufacturing Corporation | 2018-05-11 | Traditional | PDF ↗ |
| K173768 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies , Ltd. | 2018-01-10 | Special | PDF ↗ |
| K172966 | CMS-2000 Central Monitoring System | Advanced Instumentations, Inc. | 2017-12-08 | Traditional | PDF ↗ |
| K171901 | uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-11-15 | Traditional | PDF ↗ |
| K172226 | MX40 Release B.07 | Philips Medical Systems | 2017-11-09 | Traditional | PDF ↗ |
| K171580 | Monitor B125, Monitor B105 | Ge Medical Systems (China) Co., Ltd. | 2017-11-01 | Traditional | PDF ↗ |
| K171801 | IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable | Philips Medizin Systeme Boeblingen GmbH | 2017-10-06 | Abbreviated | PDF ↗ |
| K170876 | Passport Series Patient Monitors(Passport 12m, Passport 17m) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-08-23 | Traditional | PDF ↗ |
| K163584 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2017-07-07 | Traditional | PDF ↗ |
| K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies , Ltd. | 2017-07-06 | Traditional | PDF ↗ |
| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor | Welch Allyn, Inc. | 2017-06-30 | Special | PDF ↗ |
| K170155 | EK12 Algorithm | Ge Medical Systems Information Technologies, Inc. | 2017-06-06 | Traditional | PDF ↗ |
| K170514 | Central Monitoring System | Guangdong Biolight Meditech Co., Ltd. | 2017-05-24 | Traditional | PDF ↗ |
| K163459 | Nihon Kohden Vital Sign Telemeter | Nihon Kohden Corporation | 2017-04-04 | Traditional | PDF ↗ |
| K161056 | Telemetry Transmitter | Edan Instruments, Inc. | 2017-02-03 | Traditional | PDF ↗ |
| K161517 | Mortara Surveyor Patient Monitor | Mortara Instrument, Inc. | 2017-01-11 | Traditional | PDF ↗ |
| K160981 | Patient Monitor | Edan Instruments, Inc. | 2016-12-22 | Traditional | PDF ↗ |
| K153707 | Nihon Kohden Vital Sign Telemeter | Nihon Kohden Corporation | 2016-09-02 | Traditional | PDF ↗ |
| K160685 | Surveyor S4 Mobile Monitor | Mortara Instrument, Inc. | 2016-08-04 | Traditional | PDF ↗ |
Product code MHX · Class II · Cardiovascular. Data: openFDA.