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
97–120 of 425
Cleared Sep 02, 2015
Panorama Patient Monitoring Network
K150082
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 230d
Cleared Sep 02, 2015
V Series Monitoring System (including V12 and V21 Monitors)
K150352
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 203d
Cleared Sep 02, 2015
Infinity CentralStation Wide
K151860
Draeger Medical Systems, Inc.
Cardiovascular · 56d
Cleared Jun 25, 2015
Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors
K150975
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 73d
Cleared Mar 16, 2015
Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor
K150030
Fukuda Denshi USA, Inc.
Cardiovascular · 67d
Cleared Feb 12, 2015
FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR
K134046
Fukuda Denshi USA, Inc.
Cardiovascular · 408d
Cleared Nov 19, 2014
MORTARA MONITORING WAVEFORM VIEWER
K141811
Mortara Instrument, Inc.
Cardiovascular · 135d
Cleared Mar 20, 2014
IM60/IM70 PATIENT MONITOR
K131971
Edan Instruments, Inc.
Cardiovascular · 265d
Cleared Dec 03, 2013
SURVEYOR CENTRAL STATION
K131929
Mortara Instrument, Inc.
Cardiovascular · 159d
Cleared Aug 12, 2013
PHILIPS SURESIGNS CENTRAL
K131032
Philips Medical Systems
Cardiovascular · 122d
Cleared Jul 03, 2013
IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS
K123074
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 275d
Cleared Jun 21, 2013
MFM-CMS CENTRAL MONITORING SYSTEM
K120727
Edan Instruments, Inc.
Cardiovascular · 469d
Cleared Apr 18, 2013
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8
K123900
Philips Medical Systems
Cardiovascular · 121d
Cleared Apr 11, 2013
INFINITY CENTRALSTATION WITH INFINITY M300
K130711
Draeger Medical Systems, Inc.
Cardiovascular · 27d
Cleared Mar 22, 2013
MORTARA SURVEYOR PATIENT MONITOR
K123556
Mortara Instrument, Inc.
Cardiovascular · 123d
Cleared Aug 29, 2012
INTELLIVUE PATIENT MONITOR
K122439
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 19d
Cleared May 16, 2012
PATIENT MONITOR
K120173
Edan Instruments, Inc.
Cardiovascular · 117d
Cleared Mar 29, 2012
SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
K120616
Spacelabs Medical, Inc.
Cardiovascular · 29d
Cleared Mar 22, 2012
INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET
K113798
Draeger Medical Systems, Inc.
Cardiovascular · 90d
Cleared Feb 06, 2012
PATIENT MONITOR
K113653
Edan Instruments, Inc.
Cardiovascular · 56d
Cleared Feb 01, 2012
PATIENT MONITOR
K113623
Edan Instruments, Inc.
Cardiovascular · 58d
Cleared Nov 02, 2011
SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
K112962
Spacelabs Medical, Inc.
Cardiovascular · 28d
Cleared Jul 20, 2011
PATIENT MONITOR
K110922
Edan Instruments, Inc.
Cardiovascular · 110d
Cleared Mar 11, 2011
FUKUDA DENSHI
K103134
Fukuda Denshi USA, Inc.
Cardiovascular · 137d