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 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K161531 | IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800 | Philips Medizin Systeme Boeblingen GmbH | 2016-07-01 | Special | PDF ↗ |
| K153702 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2016-06-13 | Traditional | PDF ↗ |
| K160951 | Philips Efficia CMS200 Central Monitoring System | Philips Medical Systems | 2016-05-05 | Special | PDF ↗ |
| K152552 | Patient Monitor | Edan Instruments, Inc. | 2016-04-29 | Traditional | PDF ↗ |
| K152973 | Dyna-Vision Telemonitoring System | Techmedic Development International B.V. | 2016-04-29 | Traditional | PDF ↗ |
| K153160 | AVIVO Mobile Patient Management (MPM) System | Medtronic, Inc. | 2016-03-30 | Special | PDF ↗ |
| K153448 | Passport Series Patient Monitors (Including Passport 8, Passport 12) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016-03-03 | Traditional | PDF ↗ |
| K153275 | Aingeal Activity System | Intelesens, Ltd. | 2016-02-26 | Traditional | PDF ↗ |
| K152902 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016-02-18 | Traditional | PDF ↗ |
| K151812 | PATIENT MONITORS VARIOUS MODELS | Philips Medical Systems | 2016-01-26 | Traditional | PDF ↗ |
| K151063 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2015-12-15 | Special | PDF ↗ |
| K150329 | elance Vital Signs Monitor, Central Monitor Software | Spacelabs Healthcare | 2015-11-05 | Traditional | PDF ↗ |
| K151080 | Nihon Kohden CSM 1901 Bedside Monitor | Nihon Kohden | 2015-11-05 | Traditional | PDF ↗ |
| K151027 | zensor system | Intelesens Limited | 2015-10-02 | Traditional | PDF ↗ |
| K152407 | Infinity Delta, Infinity Delta XL, Infinity Kappa | Draeger Medical Sytems, Inc. | 2015-09-23 | Special | PDF ↗ |
| K150352 | V Series Monitoring System (including V12 and V21 Monitors) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-09-02 | Traditional | PDF ↗ |
| K150082 | Panorama Patient Monitoring Network | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-09-02 | Traditional | PDF ↗ |
| K151860 | Infinity CentralStation Wide | Draeger Medical Systems, Inc. | 2015-09-02 | Traditional | PDF ↗ |
| K143676 | B40i Patient Monitor | GE Healthcare Finland Oy | 2015-07-31 | Traditional | PDF ↗ |
| K142827 | Visi Mobile Monitoring System, Visi Mobile Chest Sensor | Sotera Wireless, Inc. | 2015-07-20 | Abbreviated | PDF ↗ |
| K150975 | Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors | Philips Medizin Systeme Boeblingen GmbH | 2015-06-25 | Special | PDF ↗ |
| K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor | Fukuda Denshi USA, Inc. | 2015-03-16 | Traditional | PDF ↗ |
| K134046 | FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR | Fukuda Denshi USA, Inc. | 2015-02-12 | Traditional | PDF ↗ |
| K141963 | 12SL ECG ANALYSIS PROGRAM | Ge Medical Systems Information Technologies, Inc. | 2015-02-05 | Traditional | PDF ↗ |
| K143195 | Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2014-12-22 | Traditional | PDF ↗ |
| K141811 | MORTARA MONITORING WAVEFORM VIEWER | Mortara Instrument, Inc. | 2014-11-19 | Abbreviated | PDF ↗ |
| K142601 | Panorama Patient Monitoring Network | Shenzhen Mindray Bio-Medical Electronics Co. | 2014-11-14 | Abbreviated | PDF ↗ |
| K141156 | SPACELABS HEALTHCARE TELEMETRY RECEIVER | Spacelabs Healthcare | 2014-09-09 | Traditional | PDF ↗ |
| K133222 | SAAD PATIENT MONITOR (SPM) | Hanin Medical Services Co., Ltd. | 2014-08-06 | Traditional | PDF ↗ |
| K132662 | PASSPORT SERIES PATIENT MONITORS | Shenzhen Mindray Biomedical Electronics Co., Ltd. | 2014-08-01 | Special | PDF ↗ |
| K141015 | INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2014-05-19 | Special | PDF ↗ |
| K132077 | PATIENT MONITOR | Advanced Instrumentations, Inc. | 2014-04-23 | Traditional | PDF ↗ |
| K132075 | PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M) | Mindray North America | 2014-04-18 | Abbreviated | PDF ↗ |
| K131971 | IM60/IM70 PATIENT MONITOR | Edan Instruments, Inc. | 2014-03-20 | Traditional | PDF ↗ |
| K131876 | M SERIES PATIENT MONITOR | Mid-Link Consulting Co, Ltd. | 2014-02-27 | Special | PDF ↗ |
| K133576 | MONITOR B40 | Ge Medical Systems China Co., Ltd. | 2014-02-21 | Special | PDF ↗ |
| K130401 | ALERTWATCH: OR | Alertwatch, LLC | 2014-02-07 | Traditional | PDF ↗ |
| K132026 | V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 | Mindray DS USA, Inc. | 2013-12-20 | Abbreviated | PDF ↗ |
| K130208 | BERNOULLI ENTERPRISE SOFTWARE | Cardiopulmonary Corp. | 2013-12-20 | Traditional | PDF ↗ |
| K132533 | CARESCAPE MONITOR B450 | GE Healthcare Finland Oy | 2013-12-04 | Traditional | PDF ↗ |
| K131929 | SURVEYOR CENTRAL STATION | Mortara Instrument, Inc. | 2013-12-03 | Abbreviated | PDF ↗ |
| K131872 | INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2013-10-17 | Special | PDF ↗ |
| K131223 | CARESCAPE MONITOR B650 | GE Healthcare Finland Oy | 2013-08-28 | Traditional | PDF ↗ |
| K131414 | CARESCAPE MONITOR B850 | GE Healthcare Finland Oy | 2013-08-28 | Traditional | PDF ↗ |
| K131829 | INTELLIVUE PATIENT MONITOR | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2013-08-16 | Special | PDF ↗ |
| K131032 | PHILIPS SURESIGNS CENTRAL | Philips Medical Systems | 2013-08-12 | Traditional | PDF ↗ |
| K131763 | TRUSCOPE SERIES PATIENT MONITOR | Guangdong Biolight Meditech Co., Ltd. | 2013-07-15 | Special | PDF ↗ |
| K123074 | IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013-07-03 | Traditional | PDF ↗ |
| K130584 | MONITOR B40 | Ge Medical Systems China Co., Ltd. | 2013-06-26 | Traditional | PDF ↗ |
| K120727 | MFM-CMS CENTRAL MONITORING SYSTEM | Edan Instruments, Inc. | 2013-06-21 | Traditional | PDF ↗ |
| K130849 | INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2013-06-14 | Special | PDF ↗ |
| K122146 | XHIBIT CENTRAL STATION, MODEL 96102 | Spacelabs Healthcare | 2013-04-22 | Traditional | PDF ↗ |
| K123900 | SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 | Philips Medical Systems | 2013-04-18 | Special | PDF ↗ |
| K130711 | INFINITY CENTRALSTATION WITH INFINITY M300 | Draeger Medical Systems, Inc. | 2013-04-11 | Special | PDF ↗ |
| K122253 | PROCARE MONITOR B20 | Ge Medical Systems China Co., Ltd. | 2013-03-22 | Special | PDF ↗ |
| K123556 | MORTARA SURVEYOR PATIENT MONITOR | Mortara Instrument, Inc. | 2013-03-22 | Abbreviated | PDF ↗ |
| K123472 | CIMVA UNIVERSAL | Therapeutic Monitoring Systems (Tms), Inc. | 2013-03-05 | Traditional | PDF ↗ |
| K123048 | PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO | Advanced Instrumentations, Inc. | 2013-01-11 | Traditional | PDF ↗ |
| K122439 | INTELLIVUE PATIENT MONITOR | Philips Medizin Systeme Boeblingen GmbH | 2012-08-29 | Special | PDF ↗ |
| K113045 | BIOHARNESS | Zephyr Technology Corporation | 2012-08-14 | Traditional | PDF ↗ |
| K120598 | PROCARE MONITOR B40 | Ge Medical Systems China Co., Ltd. | 2012-07-19 | Traditional | PDF ↗ |
| K120366 | INTELLIVUE PATIENT MONITOR | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2012-07-18 | Abbreviated | PDF ↗ |
| K121367 | ZOLL PROPAQ XM | ZOLL Medical Corporation | 2012-06-21 | Traditional | PDF ↗ |
| K121480 | ARIATELE TELEMETRY TRANSMITTER (96281) | Spacelabs Healthcare | 2012-06-06 | Special | PDF ↗ |
| K120631 | PATIENT MONITOR | Advanced Instruments, Inc. | 2012-05-25 | Traditional | PDF ↗ |
| K120173 | PATIENT MONITOR | Edan Instruments, Inc. | 2012-05-16 | Traditional | PDF ↗ |
| K120616 | SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 | Spacelabs Medical, Inc. | 2012-03-29 | Special | PDF ↗ |
| K113657 | INTELLIVUE PATIENT MONITOR | Philips Medizin Systeme Boblingen GmbH | 2012-03-22 | Traditional | PDF ↗ |
| K113798 | INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET | Draeger Medical Systems, Inc. | 2012-03-22 | Traditional | PDF ↗ |
| K113441 | PHYSIOLOGICAL MONITOR, PATIENT MONITOR | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2012-03-22 | Traditional | PDF ↗ |
| K113054 | EQUIVITAL | Hidalgo Limited | 2012-02-17 | Special | PDF ↗ |
| K113653 | PATIENT MONITOR | Edan Instruments, Inc. | 2012-02-06 | Traditional | PDF ↗ |
| K113623 | PATIENT MONITOR | Edan Instruments, Inc. | 2012-02-01 | Traditional | PDF ↗ |
| K113187 | AVIVO MOBILE PATIENT MANAGEMENT | Corventis, Inc. | 2012-01-04 | Abbreviated | PDF ↗ |
| K112637 | NETKONNECT REMOTE NETWORK EXTENSION | Nihon Kohden | 2011-12-09 | Special | PDF ↗ |
| K112190 | PATIENT MONITOR | Mediana Co., Ltd. | 2011-11-09 | Traditional | PDF ↗ |
| K112962 | SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) | Spacelabs Medical, Inc. | 2011-11-02 | Special | PDF ↗ |
| K112803 | PATIENT MONITOR | Guangdong Biolight Meditech Co., Ltd. | 2011-10-24 | Special | PDF ↗ |
| K110922 | PATIENT MONITOR | Edan Instruments, Inc. | 2011-07-20 | Traditional | PDF ↗ |
| K101692 | PATIENT MONITOR | Contec Medical System Co., Ltd. | 2011-06-28 | Traditional | PDF ↗ |
| K110953 | VISENSIA, VISENSIA WITH ALERT | Obs Medical | 2011-06-15 | Special | PDF ↗ |
| K110015 | VITALSENS, AINGEAL, V-POD | Intelesens Limited | 2011-05-20 | Traditional | PDF ↗ |
| K110622 | INTELLIVUE PATIENT MONITOR | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011-03-31 | Special | PDF ↗ |
| K103134 | FUKUDA DENSHI | Fukuda Denshi USA, Inc. | 2011-03-11 | Traditional | PDF ↗ |
| K103652 | SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8 | Philips Medical Systesms | 2011-01-13 | Special | PDF ↗ |
| K103646 | INTELLIVUE MX40 PATIENT MONITOR | Phillips Medical Systems | 2011-01-07 | Special | PDF ↗ |
| K102422 | SPACELABS MEDICAL PATIENT MONITORS | Spacelabs Medical, Inc. | 2010-12-07 | Special | PDF ↗ |
| K102376 | NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 | Nihon Kohden Corp. | 2010-12-07 | Special | PDF ↗ |
| K100040 | BIOHARNESS | Zephyr Technology Corporation | 2010-12-03 | Traditional | PDF ↗ |
| K101619 | WELCH ALLYN 1500 PATIENT MONITOR | Schiller AG | 2010-11-12 | Traditional | PDF ↗ |
| K102562 | INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800 | Philips Medizin Systeme Boblingen GmbH | 2010-10-21 | Special | PDF ↗ |
| K102239 | CARESCAPE MONITOR B650 | GE Healthcare Finland Oy | 2010-10-18 | Traditional | PDF ↗ |
| K102495 | M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0 | Philips Medical Systems | 2010-09-30 | Special | PDF ↗ |
| K102040 | PATIENT MONITOR | Guangdong Biolight Meditech Co., Ltd. | 2010-09-24 | Special | PDF ↗ |
| K102004 | ENDEAVOUR MONITORING SYSTEM | Mindray DS USA, Inc. | 2010-09-10 | Abbreviated | PDF ↗ |
| K092449 | BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-08-30 | Traditional | PDF ↗ |
| K101521 | ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O | Philips Medical Systems | 2010-07-29 | Special | PDF ↗ |
| K101449 | INTELLIVUE PATIENT MONITOR | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010-06-18 | Special | PDF ↗ |
| K100217 | LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 | Mediana Co., Ltd. | 2010-06-08 | Traditional | PDF ↗ |
| K093268 | INTELLIVUE PATIENT MONITOR | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010-05-11 | Traditional | PDF ↗ |
Product code MHX · Class II · Cardiovascular. Data: openFDA.