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
241–264 of 425
Cleared Jul 19, 2002
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE
K021279
Datex-Ohmeda
Cardiovascular · 88d
Cleared May 15, 2002
PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02
K021422
Philips Medical Systems
Cardiovascular · 12d
Cleared Mar 21, 2002
DINAMAP PRO 1000 MONITOR, MODEL 1000
K012915
Ge Medical Systems Information Technologies
Cardiovascular · 203d
Cleared Mar 20, 2002
PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A
K020531
Philips Medical Systems
Cardiovascular · 29d
Cleared Feb 12, 2002
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0
K014261
Philips Medical Systems, Inc.
Cardiovascular · 47d
Cleared Feb 06, 2002
VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07
K011540
Datascope Corp.
Cardiovascular · 264d
Cleared Jan 23, 2002
KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E
K010923
Siemens Elema AB
Cardiovascular · 302d
Cleared Jan 17, 2002
SIEMENS INFINITY GATEWAY SUITE
K014213
Siemens Medical Solutions USA, Inc.
Cardiovascular · 27d
Cleared Nov 29, 2001
MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A
K013427
Philips Medical Systems, Inc.
Cardiovascular · 44d
Cleared Nov 28, 2001
PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B
K013199
Philips Medical Systems, Inc.
Cardiovascular · 64d
Cleared Sep 12, 2001
NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES
K011918
Nihon Kohden America, Inc.
Cardiovascular · 84d
Cleared Jul 20, 2001
INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II
K012016
Siemens Medical Solutions USA, Inc.
Cardiovascular · 22d
Cleared Dec 21, 2000
SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000
K003243
Siemens Medical Solutions USA, Inc.
Cardiovascular · 65d
Cleared Dec 21, 2000
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K003248
Siemens Medical Solutions USA, Inc.
Cardiovascular · 65d
Cleared Nov 07, 2000
CNS-9300 SERIES CENTRAL STATION
K001433
Nihon Kohden America, Inc.
Cardiovascular · 183d
Cleared Oct 24, 2000
LIFE SCOPE P, MODEL BSM-4100 SERIES
K001693
Nihon Kohden America, Inc.
Cardiovascular · 144d
Cleared Oct 05, 2000
S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08
K002478
Datex-Ohmeda, Inc.
Cardiovascular · 55d
Cleared Sep 06, 2000
S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE
K002158
Datex-Ohmeda, Inc.
Cardiovascular · 51d
Cleared Aug 31, 2000
LIFE SCOPE EC, MODEL BSM-1102
K000517
Nihon Kohden America, Inc.
Cardiovascular · 197d
Cleared Jun 08, 2000
AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)
K000815
Datex-Ohmeda
Cardiovascular · 87d
Cleared Jun 05, 2000
DATEX-OHMEDA CS/3 TELEMETRY SYSTEM
K000882
Datex-Ohmeda
Cardiovascular · 77d
Cleared Apr 13, 2000
CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)
K000168
Datex-Ohmeda
Cardiovascular · 84d
Cleared Apr 13, 2000
DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR)
K993608
Datex-Ohmeda, Inc.
Cardiovascular · 171d
Cleared Feb 22, 2000
SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR
K993974
Siemens Medical Solutions USA, Inc.
Cardiovascular · 90d