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
Jun 21, 2013K120727MFM-CMS CENTRAL MONITORING SYSTEM
Edan Instruments, Inc., CN
MHX
Jun 14, 2013K130849INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, DE
MHX
Apr 22, 2013K122146XHIBIT CENTRAL STATION, MODEL 96102
Spacelabs Healthcare
MHX
Apr 18, 2013K123900SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8
Philips Medical Systems
MHX
Apr 11, 2013K130711INFINITY CENTRALSTATION WITH INFINITY M300
Draeger Medical Systems, Inc.
MHX
Mar 22, 2013K123556MORTARA SURVEYOR PATIENT MONITOR
Mortara Instrument, Inc.
MHX
Mar 22, 2013K122253PROCARE MONITOR B20
Ge Medical Systems China Co., Ltd.
MHX
Mar 5, 2013K123472CIMVA UNIVERSAL
Therapeutic Monitoring Systems (Tms), Inc.
MHX
Jan 11, 2013K123048PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO
Advanced Instrumentations, Inc.
MHX
Aug 29, 2012K122439INTELLIVUE PATIENT MONITOR
Philips Medizin Systeme Boeblingen GmbH, DE
MHX
Aug 14, 2012K113045BIOHARNESS
Zephyr Technology Corporation
MHX
Jul 19, 2012K120598PROCARE MONITOR B40
Ge Medical Systems China Co., Ltd.
MHX
Jul 18, 2012K120366INTELLIVUE PATIENT MONITOR
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, DE
MHX
Jun 21, 2012K121367ZOLL PROPAQ XM
ZOLL Medical Corporation
MHX
Jun 6, 2012K121480ARIATELE TELEMETRY TRANSMITTER (96281)
Spacelabs Healthcare
MHX
May 25, 2012K120631PATIENT MONITOR
Advanced Instruments, Inc.
MHX
May 16, 2012K120173PATIENT MONITOR
Edan Instruments, Inc., CN
MHX
Mar 29, 2012K120616SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
Spacelabs Medical, Inc.
MHX
Mar 22, 2012K113798INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET
Draeger Medical Systems, Inc.
MHX
Mar 22, 2012K113657INTELLIVUE PATIENT MONITOR
Philips Medizin Systeme Boblingen GmbH, DE
MHX
Mar 22, 2012K113441PHYSIOLOGICAL MONITOR, PATIENT MONITOR
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, DE
MHX
Feb 17, 2012K113054EQUIVITAL
Hidalgo Limited, GB
MHX
Feb 6, 2012K113653PATIENT MONITOR
Edan Instruments, Inc., CN
MHX
Feb 1, 2012K113623PATIENT MONITOR
Edan Instruments, Inc., CN
MHX
Jan 4, 2012K113187AVIVO MOBILE PATIENT MANAGEMENT
Corventis, Inc.
MHX
Dec 9, 2011K112637NETKONNECT REMOTE NETWORK EXTENSION
Nihon Kohden
MHX
Nov 9, 2011K112190PATIENT MONITOR
Mediana Co., Ltd.
MHX
Nov 2, 2011K112962SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
Spacelabs Medical, Inc.
MHX
Oct 24, 2011K112803PATIENT MONITOR
Guangdong Biolight Meditech Co., Ltd., CN
MHX
Jul 20, 2011K110922PATIENT MONITOR
Edan Instruments, Inc., CN
MHX
Jun 28, 2011K101692PATIENT MONITOR
Contec Medical System Co., Ltd., CN
MHX
Jun 15, 2011K110953VISENSIA, VISENSIA WITH ALERT
Obs Medical, GB
MHX
May 20, 2011K110015VITALSENS, AINGEAL, V-POD
Intelesens Limited
MHX
Mar 31, 2011K110622INTELLIVUE PATIENT MONITOR
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, DE
MHX
Mar 11, 2011K103134FUKUDA DENSHI
Fukuda Denshi USA, Inc.
MHX
Jan 13, 2011K103652SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8
Philips Medical Systesms
MHX
Jan 7, 2011K103646INTELLIVUE MX40 PATIENT MONITOR
Phillips Medical Systems
MHX
Dec 7, 2010K102422SPACELABS MEDICAL PATIENT MONITORS
Spacelabs Medical, Inc.
MHX
Dec 7, 2010K102376NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201
Nihon Kohden Corp.
MHX
Dec 3, 2010K100040BIOHARNESS
Zephyr Technology Corporation
MHX
Nov 12, 2010K101619WELCH ALLYN 1500 PATIENT MONITOR
Schiller AG, CH
MHX
Oct 21, 2010K102562INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800
Philips Medizin Systeme Boblingen GmbH, DE
MHX
Oct 18, 2010K102239CARESCAPE MONITOR B650
GE Healthcare Finland Oy, FI
MHX
Sep 30, 2010K102495M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0
Philips Medical Systems
MHX
Sep 24, 2010K102040PATIENT MONITOR
Guangdong Biolight Meditech Co., Ltd., CN
MHX
Sep 10, 2010K102004ENDEAVOUR MONITORING SYSTEM
Mindray DS USA, Inc.
MHX
Aug 30, 2010K092449BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
MHX
Jul 29, 2010K101521ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O
Philips Medical Systems
MHX
Jun 18, 2010K101449INTELLIVUE PATIENT MONITOR
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, DE
MHX
Jun 8, 2010K100217LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30
Mediana Co., Ltd.
MHX

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