FDA Product Code
FDA Product Code MSX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2300
510(k) Clearances — 120 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261287 | Digistat Care | Ascom Ums Srl Unipersonale | 2026-09-12 | Traditional | PDF ↗ |
| K260211 | Dashboard (P007000) | Hill-Rom, Inc. | 2026-08-13 | Traditional | PDF ↗ |
| K261367 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2026-07-26 | Traditional | PDF ↗ |
| K253654 | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH | 2026-03-30 | Traditional | PDF ↗ |
| K243270 | TigerConnect Alarm Management | Tigerconnect | 2025-09-30 | Traditional | PDF ↗ |
| K242728 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-07-31 | Traditional | PDF ↗ |
| K242750 | Central Station | Nihon Kohden Digital Health Solutions, LLC | 2025-06-05 | Traditional | PDF ↗ |
| K242842 | ANNE View, Central Hub | Sibel Health, Inc. | 2025-01-08 | Traditional | PDF ↗ |
| K241397 | Hinscope | Hinlab Sas | 2024-11-14 | Traditional | PDF ↗ |
| K233834 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2024-07-12 | Traditional | PDF ↗ |
| K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 2024-05-09 | Traditional | PDF ↗ |
| K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2024-03-22 | Traditional | PDF ↗ |
| K231506 | Current Health System | Current Health , Ltd. | 2023-08-24 | Special | PDF ↗ |
| K223567 | CNS-2101 Central Monitor | Nihon Kohden Corporation | 2023-07-31 | Traditional | PDF ↗ |
| K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | 2023-02-23 | Traditional | PDF ↗ |
| K222550 | Current Health System | Current Health , Ltd. | 2022-11-01 | Special | PDF ↗ |
| K203579 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2022-06-07 | Traditional | PDF ↗ |
| K211046 | eCareManager 4.5 | Visicu, Inc. | 2022-06-03 | Traditional | PDF ↗ |
| K220058 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-06-01 | Traditional | PDF ↗ |
| K212622 | Zyter RPM | Zyter, Inc. | 2022-02-11 | Traditional | PDF ↗ |
| K211949 | AirStrip ONE Web Client with Alarm Communication Management (ACM) | Airstrip Technologies, Inc. | 2021-12-09 | Special | PDF ↗ |
| K210160 | AlertWatch:AC | Alertwatch, Inc. | 2021-09-10 | Traditional | PDF ↗ |
| K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021-09-03 | Traditional | PDF ↗ |
| K193421 | Smart Alarm Interface | Boxview, LLC | 2020-10-30 | Traditional | PDF ↗ |
| K202497 | Aulisa Multiple Patient Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2020-10-30 | Traditional | PDF ↗ |
| K192952 | Spire Health Remote Patient Monitoring System | Spire, Inc. D/B/A Spire Health | 2020-06-05 | Traditional | PDF ↗ |
| K193391 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-21 | Special | PDF ↗ |
| K193043 | Critical Alert CommonPath Enterprise | Critical Alert | 2020-05-11 | Traditional | PDF ↗ |
| K191272 | Wearable Device, Wearable Package | Current Health , Ltd. | 2019-07-12 | Traditional | PDF ↗ |
| K182637 | Philips IntelliVue XDS Software | Philips Medizin Systeme Boeblingen GmbH | 2019-04-26 | Traditional | PDF ↗ |
| K190073 | Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub | Current Health , Ltd. | 2019-03-27 | Traditional | PDF ↗ |
| K183238 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-03-13 | Traditional | PDF ↗ |
| K180430 | Digistat Smart Central | Ascom Ums Srl Unipersonale | 2018-11-23 | Traditional | PDF ↗ |
| K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package | Snap40, Ltd. | 2018-11-14 | Traditional | PDF ↗ |
| K180566 | Unite Connect for Clinical Systems | Ascom Sweden AB | 2018-04-03 | Special | PDF ↗ |
| K173203 | Athena GTX Device Management Suite (ADMS) Software | Athena Gtx | 2018-03-14 | Traditional | PDF ↗ |
| K171322 | eCareManager 4.1 | Visicu, Inc. | 2017-08-03 | Traditional | PDF ↗ |
| K162607 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-04-20 | Traditional | PDF ↗ |
| K153156 | eCareManager 4.0.1 | Visicu, Inc. | 2016-09-30 | Traditional | PDF ↗ |
| K160862 | AirStrip RPM | Airstrip Technologies, Inc. | 2016-09-19 | Traditional | PDF ↗ |
| K161164 | CareEvent inclusive of the CareEvent Mobile Application accessory | Philips Medical Systems | 2016-06-24 | Traditional | PDF ↗ |
| K151672 | Cerner CareAware Event Management | Cerner Corporation | 2015-12-21 | Traditional | PDF ↗ |
| K151006 | EarlySense Central Display Station (CDS) | Earlysense, Ltd. | 2015-08-31 | Traditional | PDF ↗ |
| K150632 | Hypervisor IX Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-07-06 | Traditional | PDF ↗ |
| K140852 | VECTRAPLEX CMS | Vectracor, Inc. | 2015-01-30 | Traditional | PDF ↗ |
| K142935 | CareEvent | Philips Medical Systems | 2015-01-15 | Special | PDF ↗ |
| K141756 | INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION | Draeger Medical Systems, Inc. | 2014-12-12 | Traditional | PDF ↗ |
| K143057 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2014-12-03 | Special | PDF ↗ |
| K132036 | HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2014-07-01 | Abbreviated | PDF ↗ |
| K130707 | ISIRONA MAGELLAN | Isirona, LLC | 2013-11-20 | Traditional | PDF ↗ |
| K130339 | CLINICAL ALERT NOTIFICATION | Extension , Inc. | 2013-07-11 | Traditional | PDF ↗ |
| K121865 | ZOLL RESCUENET 12-LEAD | ZOLL Medical Corporation | 2012-11-20 | Traditional | PDF ↗ |
| K121712 | AIRSTRIP RPM FOR LIFENET CONSULT | Airstrip Technologies, Inc. | 2012-11-20 | Traditional | PDF ↗ |
| K121885 | EARLYSENSE CENTRAL DISPLAY SYSTEM | Earlysense, Ltd. | 2012-09-10 | Special | PDF ↗ |
| K112650 | CONNEXALL SUITE OF SOFTWARE PRODUCTS | Connexall USA, Inc. | 2012-02-01 | Traditional | PDF ↗ |
| K112282 | M VISUM ALERT ALARM MANAGEMENT SYSTEM | Mvisum, Inc. | 2011-11-04 | Traditional | PDF ↗ |
| K111296 | ZOLL RESCUENETLINK | Zoll Medical Corporation, World Wide Headquarters | 2011-10-27 | Traditional | PDF ↗ |
| K112047 | AMCOM COMMTECH MESSENGER | Amcom Software,Inc. | 2011-09-13 | Traditional | PDF ↗ |
| K111215 | ASCOM MOBILE MONITORING GATEWAY (MMG) | Ascom (Sweden) AB | 2011-07-05 | Traditional | PDF ↗ |
| K110521 | EVERON CENTRAL DISPLAY STATION (CDS) | Earlysense, Ltd. | 2011-04-19 | Special | PDF ↗ |
| K103634 | ASCOM CLINICALCONNEX CARDIOMAX | Ascom (Us), Inc. | 2011-02-23 | Traditional | PDF ↗ |
| K102974 | INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00 | Philips Medical Systems | 2011-01-04 | Traditional | PDF ↗ |
| K102757 | LIFENET SYSTEM | Physio-Control, Inc. | 2010-11-05 | Special | PDF ↗ |
| K100376 | EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 | Earlysense, Ltd. | 2010-08-06 | Traditional | PDF ↗ |
| K093925 | LIFENET SYSTEM | Physio-Control, Inc. | 2010-01-12 | Special | PDF ↗ |
| K091176 | PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441 | Philips Medical Systems | 2009-11-13 | Traditional | PDF ↗ |
| K080192 | HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-04-03 | Traditional | PDF ↗ |
| K071391 | PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521 | Philips Medical Systems, Inc. | 2007-09-07 | Traditional | PDF ↗ |
| K071047 | MASIMO PATIENT SAFETY NET | Masimo Corporation | 2007-06-08 | Traditional | PDF ↗ |
| K070204 | LINK TO ACUITY CLINICIAN NOTIFIER | Welch Allyn Protocol, Inc. | 2007-03-23 | Special | PDF ↗ |
| K070421 | DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02 | GE Healthcare | 2007-03-13 | Special | PDF ↗ |
| K061428 | PMP4 APPLICATION | Card Guard Scientific Survival , Ltd. | 2006-10-16 | Traditional | PDF ↗ |
| K062278 | SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 | Spacelabs Medical, Inc. | 2006-09-19 | Special | PDF ↗ |
| K061932 | BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE | Cardiopulmonary Corp. | 2006-09-14 | Traditional | PDF ↗ |
| K061994 | WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE | GE Healthcare | 2006-08-11 | Special | PDF ↗ |
| K060254 | MODIFICATION TO INFINITY EXPLORER | Draeger Medical Systems, Inc. | 2006-04-04 | Special | PDF ↗ |
| K052854 | LIFENET EXCHANGE SYSTEM | Medtronic Emergency Response Systems, Inc. | 2006-01-20 | Traditional | PDF ↗ |
| K052975 | DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE | GE Healthcare | 2006-01-20 | Special | PDF ↗ |
| K052972 | DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 | GE Healthcare | 2005-12-29 | Special | PDF ↗ |
| K051634 | DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION | GE Healthcare | 2005-07-19 | Special | PDF ↗ |
| K051283 | MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE | Cardiopulmonary Corp. | 2005-06-23 | Special | PDF ↗ |
| K042845 | THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS | Philips Medizin Systeme Boblingen GmbH | 2004-11-12 | Special | PDF ↗ |
| K042771 | GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3 | Datex-Ohmeda | 2004-10-15 | Special | PDF ↗ |
| K040945 | MODIFICATION TO INFINITY EXPLORER | Draeger Medical Systems, Inc. | 2004-05-12 | Special | PDF ↗ |
| K033281 | DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE | Datex-Ohmeda | 2003-11-26 | Traditional | PDF ↗ |
| K033078 | DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE | Datex-Ohmeda | 2003-10-29 | Special | PDF ↗ |
| K032582 | UNITY NETWORK PATIENT DATA SERVER | Ge Medical Systems Information Technologies | 2003-09-17 | Traditional | PDF ↗ |
| K032346 | UNITY NETWORK IS PATIENT VIEWER | Ge Medical Systems Information Technologies | 2003-08-05 | Special | PDF ↗ |
| K030615 | INFINITY EXPLORER | Siemens Medical Solutions USA, Inc. | 2003-03-21 | Special | PDF ↗ |
| K023497 | DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE | Datex-Ohmeda | 2002-11-04 | Special | PDF ↗ |
| K022507 | DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02 | Datex-Ohmeda | 2002-08-23 | Special | PDF ↗ |
| K020661 | UNITY IS PATIENT VIEWER | General Electric Medical Systems Information Techn | 2002-05-24 | Traditional | PDF ↗ |
| K020524 | PATIENTNET MONITORING SYSTEM | General Electric Medical Systems Information Techn | 2002-03-20 | Special | PDF ↗ |
| K020018 | MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE | Cardiopulmonary Corp. | 2002-02-21 | Traditional | PDF ↗ |
| K013387 | DATEX-OHMEDA S/5 WEB VIEWER | Datex-Ohmeda | 2002-01-08 | Traditional | PDF ↗ |
| K013246 | DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01 | Datex-Ohmeda | 2001-12-11 | Traditional | PDF ↗ |
| K012531 | DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX | Datex-Ohmeda | 2001-11-02 | Traditional | PDF ↗ |
| K013156 | MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM | Data Critical Corp. | 2001-10-19 | Special | PDF ↗ |
| K012171 | MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS | Visicu, Inc. | 2001-07-24 | Special | PDF ↗ |
| K012005 | MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM | Data Critical Corp. | 2001-07-24 | Special | PDF ↗ |
Product code MSX · Class II · Cardiovascular. Data: openFDA.