Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
FDA product code MHX · 403 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.1025
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1987-09-21 – 2026-09-01
MHX
2003-05-13
MHX
2003-05-09
C3 PATIENT MONITOR
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MHX
2003-05-06
EK-PRO ARRHYTHMIA DETECTION ALGORITHM
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MHX
2003-04-17
VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100
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MHX
2003-03-21
SIEMENS INFINITY GATEWAY SUITE, MODEL VF2
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MHX
2003-03-21
MODIFICATION TO SOLAR 9500 INFORMATION MONITOR
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MHX
2003-03-12
PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL TECHNOLOGY AND M3185 OPT C41 WIRELESS BEDSIDE ADAPTR
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MHX
2003-03-04
ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A
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MHX
2003-02-26
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
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MHX
2003-02-11
SIEMENS INFINITY SC 6002XL MODIFICATIONS
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MHX
2002-12-18
SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM
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MHX
2002-12-04
M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY
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MHX
2002-11-29
PHILIPS DRUG CALCULATOR SOFTWARE
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MHX
2002-11-19
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O
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MHX
2002-11-04
SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS
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MHX
2002-10-24
CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES
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MHX
2002-10-03
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE
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MHX
2002-09-25
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER
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MHX
2002-08-14
DASH 3000/4000 PATIENT MONITOR
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MHX
2002-07-19
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE
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MHX
2002-05-15
PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02
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MHX
2002-05-07
MODIFICATION OF APEXPRO TELEMETRY SYSTEM
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MHX
2002-04-08
MONITORING SYSTEM,MODEL ARGUS PB-1000
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MHX
2002-03-21
DINAMAP PRO 1000 MONITOR, MODEL 1000
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MHX
2002-03-20
PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A; PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.02, MODEL M1275B
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MHX
2002-02-12
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0
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MHX
2002-02-06
VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07
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MHX
2002-01-23
KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E
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MHX
2002-01-17
SIEMENS INFINITY GATEWAY SUITE
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MHX
2002-01-03
MODIFICATION TO: POCKETVIEW ECG SOFTWARE
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MHX
2001-12-03
MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I
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MHX
2001-11-29
MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A
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MHX
2001-11-28
PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B
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MHX
2001-09-12
NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES
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MHX
2001-07-20
INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II
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MHX
2001-06-29
TRAM 2001 MODULE
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MHX
2001-05-01
AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154
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MHX
2000-12-21
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
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MHX
2000-12-21
SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000; SC 7000; SC 9000XL
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MHX
2000-12-20
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0
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MHX
2000-11-07
CNS-9300 SERIES CENTRAL STATION
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MHX
2000-10-24
LIFE SCOPE P, MODEL BSM-4100 SERIES
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MHX
2000-10-05
S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08
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MHX
2000-09-06
S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE
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MHX
2000-08-31
LIFE SCOPE EC, MODEL BSM-1102
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MHX
2000-08-18
GE MARQUETTE ECG ANALYSIS PROGRAM
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MHX
2000-07-17
GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS
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MHX
2000-06-30
AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE
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MHX
2000-06-30
COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120
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MHX
2000-06-08
AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)
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MHX
2000-06-05
DATEX-OHMEDA CS/3 TELEMETRY SYSTEM
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MHX
2000-05-17
ST/AR ST AND ARRHYTHMIA SOFTWARE
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MHX
2000-05-17
MODIFICATION TO ENVOY PATIENT MONITOR
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MHX
2000-04-13
DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR)
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MHX
2000-04-13
CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)
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MHX
2000-04-10
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER
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MHX
2000-02-22
SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR
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MHX
2000-01-28
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL B
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MHX
1999-12-08
HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH
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MHX
1999-11-26
DASH 3000 PATIENT MONITOR
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MHX
1999-11-08
HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A
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MHX
1999-07-22
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTION
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MHX
1999-07-14
SOLAR 9500 INFORMATION MONITOR
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MHX
1999-06-03
SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM
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MHX
1999-03-19
SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION
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MHX
1998-12-22
CS/3 COMPACT AIRWAY MODULE, M-COVX
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MHX
1998-09-25
VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200
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MHX
1998-08-20
SABRATEK PATIENT HOME MANAGEMENT SYSTEM
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MHX
1998-08-20
NPB3900 SERIES PATIENT MONITORS
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MHX
1998-07-17
MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A
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MHX
1998-03-13
WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS
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MHX
1998-03-04
OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM
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MHX
1998-01-30
VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX 800+/MINIPACK 300
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MHX
1998-01-13
MAGLIFE C
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MHX
1997-08-18
DINAMAP COMPACT MONITOR
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MHX
1997-01-29
PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM
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MHX
1996-12-20
NPB-4000
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MHX
1996-09-27
MAGLIFE
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MHX
1995-11-02
WITT BIOMEDICAL SERIES IV
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MHX
1995-07-13
PARAMETERS MONITORES
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MHX
1995-06-20
SCHOLAR PATIENT MONITOR
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MHX
1995-06-02
MODEL 3200 VASCULAR MINI-LAB
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MHX
1995-05-17
PICIS CHART+
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MHX
1995-03-01
DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340
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MHX
1995-01-31
VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300
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MHX
1994-10-28
PORTABLE PATIENT MONITOR
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MHX
1994-07-19
VITALMAX 4000
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MHX
1993-04-01
HEWLETT-PACKARD MODEL 78730 CAREVUE 5000
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MHX
1993-03-04
ATLANTIS GUI
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MHX
1993-03-02
SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES
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MHX
1993-02-25
WITT BIOMEDICAL SERIES II-EP
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MHX
1992-12-07
PORTABLE PATIENT MONITOR
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MHX
1992-10-06
MODELS M1175A AND M1176A COMPONENT MONITORING SYST
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MHX
1992-10-01
MODEL M2350A AND M2360A WAVEVUE CENTRAL MONITOR
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MHX
1992-02-21
NGM ESTP MODULE
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MHX
1992-02-03
MINI-PACK 911 SERIES
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MHX
1992-01-10
PROPAQ 102,104,106,102EL,104EL,&106EL
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MHX
1991-12-04
DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700
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MHX
1991-10-10
VITALMAX 830 SERIES
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MHX
1991-09-10
MIDAS SYSTEM 2500, PHYSIOLOGICAL MONITORING SYSTEM
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