MHX · Class II · 21 CFR 870.1025

FDA Product Code MHX: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

Detecting life-threatening arrhythmias in real time is one of the most critical functions in patient monitoring. FDA product code MHX covers physiological patient monitors with integrated arrhythmia detection.

These systems continuously measure and display vital signs — including ECG, heart rate, blood pressure, and oxygen saturation — while automatically alerting clinicians to dangerous rhythm abnormalities. They are used in intensive care units, cardiac telemetry wards, and operating rooms.

MHX devices are Class II medical devices, regulated under 21 CFR 870.1025 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Philips Medizin Systeme Boeblingen GmbH, Ge Medical Systems Information Technologies and Philips Medical Systems.

425
Total
425
Cleared
137d
Avg days
1987
Since
425 devices
121–144 of 425
Cleared Dec 07, 2010
SPACELABS MEDICAL PATIENT MONITORS
K102422
Spacelabs Medical, Inc.
Cardiovascular · 104d
Cleared Sep 30, 2010
M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0
K102495
Philips Medical Systems
Cardiovascular · 30d
Cleared Aug 30, 2010
BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5
K092449
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 385d
Cleared Jul 29, 2010
ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O
K101521
Philips Medical Systems
Cardiovascular · 57d
Cleared May 07, 2010
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068
K101067
Philips Medical Systems
Cardiovascular · 21d
Cleared Mar 08, 2010
INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION
K093788
Draeger Medical Systems, Inc.
Cardiovascular · 89d
Cleared Feb 24, 2010
12SL ECG ANALYSIS PROGRAM
K092369
Ge Medical Systems Information Technologies
Cardiovascular · 203d
Cleared Nov 24, 2009
ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION
K093501
Spacelabs Medical, Inc.
Cardiovascular · 12d
Cleared Aug 28, 2009
CARESCAPE MONITOR B850
K092027
Ge Medical Systems Information Technologies
Cardiovascular · 53d
Cleared Apr 15, 2009
MODIFICATION TO DASH 2500 PATIENT MONITOR
K090702
Ge Medical Systems Information Technologies
Cardiovascular · 29d
Cleared Mar 23, 2009
CAPNOSTAT / CAPNOFLEX CO2 SYSTEM
K083750
Ge Medical Systems Information Technologies
Cardiovascular · 96d
Cleared Mar 19, 2009
FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M
K083697
Fukuda Denshi USA, Inc.
Cardiovascular · 94d
Cleared Dec 24, 2008
BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY
K083271
Nihon Kohden America, Inc.
Cardiovascular · 48d
Cleared Nov 26, 2008
NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES
K082785
Nihon Kohden America, Inc.
Cardiovascular · 64d
Cleared Oct 14, 2008
PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER
K081793
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 111d
Cleared Aug 29, 2008
FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR
K081891
Fukuda Denshi USA, Inc.
Cardiovascular · 58d
Cleared Aug 22, 2008
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00
K081983
Philips Medical Systems
Cardiovascular · 42d
Cleared Aug 01, 2008
MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
K082045
Spacelabs Medical, Inc.
Cardiovascular · 14d
Cleared Jun 23, 2008
BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5
K073280
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 215d
Cleared Jun 20, 2008
APEXPRO TELEMETRY SYSTEMS
K080251
Ge Medical Systems Information Technologies
Cardiovascular · 141d
Cleared Mar 28, 2008
PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION
K073550
Nihon Kohden America, Inc.
Cardiovascular · 101d
Cleared Mar 24, 2008
DASH 2500 PATIENT MONITOR
K080157
Ge Medical Systems Information Technologies
Cardiovascular · 61d
Cleared Mar 24, 2008
SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3
K080495
Philips Medical Systems
Cardiovascular · 31d
Cleared Feb 26, 2008
NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES
K080342
Nihon Kohden America, Inc.
Cardiovascular · 18d