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
73–96 of 425
Cleared Sep 04, 2018
IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension
K181314
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 110d
Cleared Aug 16, 2018
Multi-parameter Patient Monitor, models C30
K173454
Shenzhen Comen Medical Instruments Co.,Ltd
Cardiovascular · 283d
Cleared Jul 24, 2018
MX40 Release C.01
K180017
Philips Medical Systems
Cardiovascular · 203d
Cleared Jun 19, 2018
ViSi Mobile Monitoring System
K180472
Sotera Wireless, Inc.
Cardiovascular · 117d
Cleared May 11, 2018
µCor Heart Failure and Arrhythmia Management System
K172510
Zoll Manufacturing Corporation
Cardiovascular · 263d
Cleared Jan 10, 2018
Tempus Pro Patient Monitor
K173768
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 30d
Cleared Nov 15, 2017
uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)
K171901
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 142d
Cleared Nov 09, 2017
MX40 Release B.07
K172226
Philips Medical Systems
Cardiovascular · 107d
Cleared Oct 06, 2017
IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3
K171801
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 112d
Cleared Aug 23, 2017
Passport Series Patient Monitors(Passport 12m, Passport 17m)
K170876
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 152d
Cleared Jul 07, 2017
M3290B Philips IntelliVue Information Center iX
K163584
Philips Medical Systems
Cardiovascular · 199d
Cleared Jun 30, 2017
Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
K171621
Welch Allyn, Inc.
Cardiovascular · 28d
Cleared Feb 03, 2017
Telemetry Transmitter
K161056
Edan Instruments, Inc.
Cardiovascular · 295d
Cleared Jan 11, 2017
Mortara Surveyor Patient Monitor
K161517
Mortara Instrument, Inc.
Cardiovascular · 223d
Cleared Dec 22, 2016
Patient Monitor
K160981
Edan Instruments, Inc.
Cardiovascular · 259d
Cleared Aug 04, 2016
Surveyor S4 Mobile Monitor
K160685
Mortara Instrument, Inc.
Cardiovascular · 146d
Cleared Jul 01, 2016
IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2
K161531
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 29d
Cleared Jun 13, 2016
M3290B Philips IntelliVue Information Center iX
K153702
Philips Medical Systems
Cardiovascular · 173d
Cleared May 05, 2016
Philips Efficia CMS200 Central Monitoring System
K160951
Philips Medical Systems
Cardiovascular · 30d
Cleared Apr 29, 2016
Patient Monitor
K152552
Edan Instruments, Inc.
Cardiovascular · 234d
Cleared Mar 30, 2016
AVIVO Mobile Patient Management (MPM) System
K153160
Medtronic, Inc.
Cardiovascular · 149d
Cleared Mar 03, 2016
Passport Series Patient Monitors (Including Passport 8, Passport 12)
K153448
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 94d
Cleared Feb 18, 2016
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
K152902
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 140d
Cleared Jan 26, 2016
PATIENT MONITORS VARIOUS MODELS
K151812
Philips Medical Systems
Cardiovascular · 208d