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
Apr 8, 2002K012226MONITORING SYSTEM,MODEL ARGUS PB-1000
Schiller AG, CH
MHX
Mar 21, 2002K012915DINAMAP PRO 1000 MONITOR, MODEL 1000
Ge Medical Systems Information Technologies
MHX
Mar 20, 2002K020531PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A; PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.02, MODEL M1275B
Philips Medical Systems
MHX
Feb 12, 2002K014261ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0
Philips Medical Systems, Inc.
MHX
Feb 6, 2002K011540VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07
Datascope Corp.
MHX
Jan 23, 2002K010923KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E
Siemens Elema AB
MHX
Jan 17, 2002K014213SIEMENS INFINITY GATEWAY SUITE
Siemens Medical Solutions USA, Inc.
MHX
Jan 3, 2002K013311MODIFICATION TO: POCKETVIEW ECG SOFTWARE
Micromedical Industries, Ltd., AU
MHX
Dec 3, 2001K013624MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I
Philips Medizin Systeme Boblingen GmbH
MHX
Nov 29, 2001K013427MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A
Philips Medical Systems, Inc.
MHX
Nov 28, 2001K013199PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B
Philips Medical Systems, Inc.
MHX
Sep 12, 2001K011918NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES
Nihon Kohden America, Inc.
MHX
Jul 20, 2001K012016INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II
Siemens Medical Solutions USA, Inc.
MHX
Jun 29, 2001K011000TRAM 2001 MODULE
General Electric Medical Systems Information Techn
MHX
May 1, 2001K011093AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154
Agilent Technologies, Inc.
MHX
Dec 21, 2000K003248SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
Siemens Medical Solutions USA, Inc.
MHX
Dec 21, 2000K003243SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000; SC 7000; SC 9000XL
Siemens Medical Solutions USA, Inc.
MHX
Dec 20, 2000K003621ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0
Agilent Technologies, Inc.
MHX
Nov 7, 2000K001433CNS-9300 SERIES CENTRAL STATION
Nihon Kohden America, Inc.
MHX
Oct 24, 2000K001693LIFE SCOPE P, MODEL BSM-4100 SERIES
Nihon Kohden America, Inc.
MHX
Oct 5, 2000K002478S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08
Datex-Ohmeda, Inc.
MHX
Sep 6, 2000K002158S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE
Datex-Ohmeda, Inc.
MHX
Aug 31, 2000K000517LIFE SCOPE EC, MODEL BSM-1102
Nihon Kohden America, Inc.
MHX
Aug 18, 2000K002209GE MARQUETTE ECG ANALYSIS PROGRAM
General Electric Medical Systems Information Techn
MHX
Jul 17, 2000K001268GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS
General Electric Medical Systems Information Techn
MHX
Jun 30, 2000K001722AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE
Agilent Technologies Deutschland GmbH, DE
MHX
Jun 30, 2000K001664COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120
Agilent Technologies, Inc.
MHX
Jun 8, 2000K000815AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)
Datex-Ohmeda
MHX
Jun 5, 2000K000882DATEX-OHMEDA CS/3 TELEMETRY SYSTEM
Datex-Ohmeda
MHX
May 17, 2000K001348ST/AR ST AND ARRHYTHMIA SOFTWARE
Agilent Technologies, Inc.
MHX
May 17, 2000K000563MODIFICATION TO ENVOY PATIENT MONITOR
Mennen Medical , Ltd., IL
MHX
Apr 13, 2000K993608DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR)
Datex-Ohmeda, Inc.
MHX
Apr 13, 2000K000168CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)
Datex-Ohmeda
MHX
Apr 10, 2000K000854VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER
Agilent Technologies, Inc.
MHX
Feb 22, 2000K993974SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR
Siemens Medical Solutions USA, Inc.
MHX
Jan 28, 2000K992273HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL B
Hewlett-Packard GmbH, DE
MHX
Dec 8, 1999K992595HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH
Hewlett-Packard GmbH, DE
MHX
Nov 26, 1999K992929DASH 3000 PATIENT MONITOR
General Electric Medical Systems Information Techn
MHX
Nov 8, 1999K992674HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A
Hewlett-Packard GmbH, DE
MHX
Jul 22, 1999K990476HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTION
Hewlett-Packard GmbH, DE
MHX
Jul 14, 1999K990068SOLAR 9500 INFORMATION MONITOR
General Electric Medical Systems Information Techn
MHX
Jun 3, 1999K983996SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM
Spacelabs Medical, Inc.
MHX
Mar 19, 1999K990563SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION
Siemens Medical Solutions USA, Inc.
MHX
Dec 22, 1998K982091CS/3 COMPACT AIRWAY MODULE, M-COVX
Datex-Engstrom, Inc.
MHX
Sep 25, 1998K982279VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200
Bci Intl., Inc.
MHX
Aug 20, 1998K980619SABRATEK PATIENT HOME MANAGEMENT SYSTEM
Sabratek Corp.
MHX
Aug 20, 1998K980411NPB3900 SERIES PATIENT MONITORS
Analogic Corp.
MHX
Jul 17, 1998K981576MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A
Hewlett-Packard GmbH, DE
MHX
Mar 13, 1998K973474WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS
Witt Biomedical Corporation
MHX
Mar 4, 1998K971840OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM
Invivo Research, Inc.
MHX

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