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
2008-07-17
MHX
2008-06-23
BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5
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MHX
2008-06-20
APEXPRO TELEMETRY SYSTEMS
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MHX
2008-03-28
PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION
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MHX
2008-03-24
SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3
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MHX
2008-03-24
DASH 2500 PATIENT MONITOR
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MHX
2008-02-26
NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES
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MHX
2008-01-11
MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES
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MHX
2007-12-07
LIFE+CEL BATTERY
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MHX
2007-11-29
CARESCAPE V100
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MHX
2007-11-29
PM-7000 PATIENT MONITOR
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MHX
2007-08-10
PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS
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MHX
2007-06-26
PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS
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MHX
2007-06-18
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE
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MHX
2007-06-13
MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, AND MP90 INTELLIVUE PATIENT MONITORS
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MHX
2007-06-04
INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL
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MHX
2007-05-11
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE
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MHX
2007-05-09
COLIN PRESS MATE, MODEL BP S510
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MHX
2007-04-11
HYPERVISOR VI CENTRAL MONITORING SYSTEM
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MHX
2007-03-20
PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER)
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MHX
2007-02-16
INFINITY TELESMART TELEMETRY SYSTEM
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MHX
2007-02-08
MP5 INTELLIVUE PATIENT MONITOR
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MHX
2007-02-05
SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX
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MHX
2006-12-06
MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN
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MHX
2006-11-30
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170)
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MHX
2006-11-20
INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90
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MHX
2006-11-03
EQUIVITAL, MODEL EQ-01
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MHX
2006-10-12
ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810
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MHX
2006-09-29
DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES
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MHX
2006-09-29
MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
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MHX
2006-09-20
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS
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MHX
2006-09-06
PHILIPS MP5 INTELLIVUE PATIENT MONITOR
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MHX
2006-08-14
PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS
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MHX
2006-08-02
VISION VXC CENTRAL STATION, MODEL 4300
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MHX
2006-08-01
12SL ECG ANALYSIS PROGRAM
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MHX
2006-06-23
VS-800 VITAL SIGNS MONITOR
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MHX
2006-05-26
THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
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MHX
2006-05-19
ARGUS, MODEL LCM
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MHX
2006-05-15
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWARE
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MHX
2006-05-15
MORTARA SURVEYOR TELEMETRY CENTRAL STATION
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MHX
2006-04-12
INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
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MHX
2006-04-12
INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS
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MHX
2006-04-05
TRAM MODULE
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MHX
2006-03-24
THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS
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MHX
2006-02-22
INFINITY GAMMA / GAMMAXL, INFINITY VISTA
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MHX
2006-02-17
THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS
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MHX
2006-02-03
DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P)
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MHX
2006-01-20
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS
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MHX
2006-01-10
PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00
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MHX
2005-11-16
INFINITY ALPHA
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MHX
2005-11-02
INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90
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MHX
2005-11-01
DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM
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MHX
2005-10-20
M3046B COMPACT PORTABLE PATIENT MONITORS
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MHX
2005-07-20
INFINITY MONITORS WITH SCIO MODIFICATIONS
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MHX
2005-06-20
PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000
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MHX
2005-04-22
PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90
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MHX
2005-04-05
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00
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MHX
2005-02-18
DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES
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MHX
2005-02-18
INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL
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MHX
2005-02-18
INFINITY KAPPA XLT
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MHX
2005-02-11
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS
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MHX
2005-01-21
INFINITY GATEWAY SUITE, VF4
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MHX
2004-12-23
DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE
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MHX
2004-11-03
AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)
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MHX
2004-10-06
INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5
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MHX
2004-07-28
DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES
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MHX
2004-07-23
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE
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MHX
2004-07-21
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN
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MHX
2004-07-16
QUINTON Q-TE; RMS
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MHX
2004-06-04
PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS
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MHX
2004-06-03
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
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MHX
2004-06-03
FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM
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MHX
2004-06-01
CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES
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MHX
2004-06-01
CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS
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MHX
2004-05-26
FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR
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MHX
2004-05-14
INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL
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MHX
2004-05-12
INFINITY GAMMA
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MHX
2004-05-12
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN
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MHX
2004-03-22
INFINITY MODULAR MONITORS VF4 MODIFICATIONS
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MHX
2004-03-03
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II
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MHX
2004-03-01
PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50
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MHX
2004-02-26
ENVOY PATIENT MONITOR
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MHX
2004-01-15
SOLAR 9500 INFORMATION MONITOR
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MHX
2003-12-11
INFINITY GAMMAXL
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MHX
2003-12-04
POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR
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MHX
2003-11-25
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO
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MHX
2003-11-24
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
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MHX
2003-11-21
PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER
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MHX
2003-11-12
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
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MHX
2003-11-06
APEXPRO FH TELEMETRY SYSTEM
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MHX
2003-10-10
FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR
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MHX
2003-10-10
VIEWPOINT TELEMETRY SYSTEM
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MHX
2003-09-09
SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX
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MHX
2003-08-15
MODIFICATION TO: APEXPRO TELEMETRY SYSTEM
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MHX
2003-07-16
DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES
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MHX
2003-06-25
DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES
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MHX
2003-06-06
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
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MHX
2003-05-30
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1
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MHX
2003-05-29
THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20
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MHX
2003-05-21
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE
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