ClearanceBrief
Panels › Cardiovascular › Product code MHX · Class 2

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Regulation 870.1025

16510(k)s in 12 months (431 all time)
41recalls in 12 months (294 all time)
277recalls that name a 510(k)
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Top companies in MHX

Company510(k)sRecalls
GE Healthcare1052
Philips North America046
Ge Medical Systems Information Technologies348
Philips Medical Systems327
Spacelabs Healthcare433
Draeger Medical Systems, Inc.259
GE Healthcare Finland Oy1510
Philips Medizin Systeme Boeblingen GmbH250
Shenzhen Mindray Bio-Medical Electronics Co.230
Philips Electronics North America Corporation022
Decided510(k)Device and applicantCode
Aug 4, 2016K160685Surveyor S4 Mobile Monitor
Mortara Instrument, Inc.
MHX
Jul 1, 2016K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP
Philips Medizin Systeme Boeblingen GmbH, DE
MHX
Jun 13, 2016K153702M3290B Philips IntelliVue Information Center iX
Philips Medical Systems
MHX
May 5, 2016K160951Philips Efficia CMS200 Central Monitoring System
Philips Medical Systems
MHX
Apr 29, 2016K152973Dyna-Vision Telemonitoring System
Techmedic Development International B.V., NL
MHX
Apr 29, 2016K152552Patient Monitor
Edan Instruments, Inc., CN
MHX
Mar 30, 2016K153160AVIVO Mobile Patient Management (MPM) System
Medtronic, Inc.
MHX
Mar 3, 2016K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MHX
Feb 26, 2016K153275Aingeal Activity System
Intelesens, Ltd., GB
MHX
Feb 18, 2016K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MHX
Jan 26, 2016K151812PATIENT MONITORS VARIOUS MODELS
Philips Medical Systems
MHX
Dec 15, 2015K151063Monitor B40
Ge Medical Systems China Co., Ltd., CN
MHX
Nov 5, 2015K151080Nihon Kohden CSM 1901 Bedside Monitor
Nihon Kohden
MHX
Nov 5, 2015K150329elance Vital Signs Monitor, Central Monitor Software
Spacelabs Healthcare
MHX
Oct 2, 2015K151027zensor system
Intelesens Limited, GB
MHX
Sep 23, 2015K152407Infinity Delta, Infinity Delta XL, Infinity Kappa
Draeger Medical Sytems, Inc.
MHX
Sep 2, 2015K151860Infinity CentralStation Wide
Draeger Medical Systems, Inc.
MHX
Sep 2, 2015K150352V Series Monitoring System (including V12 and V21 Monitors)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MHX
Sep 2, 2015K150082Panorama Patient Monitoring Network
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MHX
Jul 31, 2015K143676B40i Patient Monitor
GE Healthcare Finland Oy, FI
MHX
Jul 20, 2015K142827Visi Mobile Monitoring System, Visi Mobile Chest Sensor
Sotera Wireless, Inc.
MHX
Jun 25, 2015K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliV
Philips Medizin Systeme Boeblingen GmbH, DE
MHX
Mar 16, 2015K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor
Fukuda Denshi USA, Inc.
MHX
Feb 12, 2015K134046FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR
Fukuda Denshi USA, Inc.
MHX
Feb 5, 2015K14196312SL ECG ANALYSIS PROGRAM
Ge Medical Systems Information Technologies, Inc.
MHX
Dec 22, 2014K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd., TW
MHX
Nov 19, 2014K141811MORTARA MONITORING WAVEFORM VIEWER
Mortara Instrument, Inc.
MHX
Nov 14, 2014K142601Panorama Patient Monitoring Network
Shenzhen Mindray Bio-Medical Electronics Co., CN
MHX
Sep 9, 2014K141156SPACELABS HEALTHCARE TELEMETRY RECEIVER
Spacelabs Healthcare
MHX
Aug 6, 2014K133222SAAD PATIENT MONITOR (SPM)
Hanin Medical Services Co., Ltd.
MHX
Aug 1, 2014K132662PASSPORT SERIES PATIENT MONITORS
Shenzhen Mindray Biomedical Electronics Co., Ltd., CN
MHX
May 19, 2014K141015INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, DE
MHX
Apr 23, 2014K132077PATIENT MONITOR
Advanced Instrumentations, Inc.
MHX
Apr 18, 2014K132075PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M)
Mindray North America
MHX
Mar 20, 2014K131971IM60/IM70 PATIENT MONITOR
Edan Instruments, Inc., CN
MHX
Feb 27, 2014K131876M SERIES PATIENT MONITOR
Mid-Link Consulting Co, Ltd., CN
MHX
Feb 21, 2014K133576MONITOR B40
Ge Medical Systems China Co., Ltd.
MHX
Feb 7, 2014K130401ALERTWATCH: OR
Alertwatch, LLC
MHX
Dec 20, 2013K132026V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21
Mindray DS USA, Inc.
MHX
Dec 20, 2013K130208BERNOULLI ENTERPRISE SOFTWARE
Cardiopulmonary Corp.
MHX
Dec 4, 2013K132533CARESCAPE MONITOR B450
GE Healthcare Finland Oy, FI
MHX
Dec 3, 2013K131929SURVEYOR CENTRAL STATION
Mortara Instrument, Inc.
MHX
Oct 17, 2013K131872INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, DE
MHX
Aug 28, 2013K131414CARESCAPE MONITOR B850
GE Healthcare Finland Oy, FI
MHX
Aug 28, 2013K131223CARESCAPE MONITOR B650
GE Healthcare Finland Oy, FI
MHX
Aug 16, 2013K131829INTELLIVUE PATIENT MONITOR
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, DE
MHX
Aug 12, 2013K131032PHILIPS SURESIGNS CENTRAL
Philips Medical Systems
MHX
Jul 15, 2013K131763TRUSCOPE SERIES PATIENT MONITOR
Guangdong Biolight Meditech Co., Ltd., CN
MHX
Jul 3, 2013K123074IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
MHX
Jun 26, 2013K130584MONITOR B40
Ge Medical Systems China Co., Ltd.
MHX

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