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
169–192 of 425
Cleared May 15, 2006
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWARE
K061185
Ge Healthcare
Cardiovascular · 17d
Cleared Apr 12, 2006
INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS
K060039
Draeger Medical Systems, Inc.
Cardiovascular · 96d
Cleared Apr 12, 2006
INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
K060223
Draeger Medical Systems, Inc.
Cardiovascular · 72d
Cleared Apr 05, 2006
TRAM MODULE
K053121
Ge Healthcare
Cardiovascular · 149d
Cleared Feb 22, 2006
INFINITY GAMMA / GAMMAXL, INFINITY VISTA
K053484
Draeger Medical Systems, Inc.
Cardiovascular · 69d
Cleared Feb 17, 2006
THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS
K060221
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 18d
Cleared Feb 03, 2006
DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P)
K051217
Ge Healthcare
Cardiovascular · 267d
Cleared Jan 20, 2006
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS
K051400
Ge Healthcare
Cardiovascular · 234d
Cleared Jan 10, 2006
PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00
K053522
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 22d
Cleared Nov 16, 2005
INFINITY ALPHA
K051658
Draeger Medical Systems, Inc.
Cardiovascular · 148d
Cleared Nov 02, 2005
INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90
K052801
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 30d
Cleared Nov 01, 2005
DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM
K052756
Ge Healthcare
Cardiovascular · 32d
Cleared Oct 20, 2005
M3046B COMPACT PORTABLE PATIENT MONITORS
K052707
Philips Medical Systems
Cardiovascular · 21d
Cleared Jul 20, 2005
INFINITY MONITORS WITH SCIO MODIFICATIONS
K051628
Draeger Medical Systems, Inc.
Cardiovascular · 30d
Cleared Jun 20, 2005
PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000
K051367
Ge Medical Systems Information Technologies
Cardiovascular · 26d
Cleared Apr 22, 2005
PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90
K050762
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 29d
Cleared Apr 05, 2005
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00
K050742
Philips Medical Systems
Cardiovascular · 14d
Cleared Feb 18, 2005
INFINITY KAPPA XLT
K042904
Draeger Medical Systems, Inc.
Cardiovascular · 120d
Cleared Feb 18, 2005
INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL
K043439
Draeger Medical Systems, Inc.
Cardiovascular · 66d
Cleared Feb 18, 2005
DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES
K043551
Datex-Ohmeda
Cardiovascular · 57d
Cleared Feb 11, 2005
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS
K050141
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 17d
Cleared Jan 21, 2005
INFINITY GATEWAY SUITE, VF4
K043549
Draeger Medical Systems, Inc.
Cardiovascular · 29d
Cleared Dec 23, 2004
DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE
K043276
Datex-Ohmeda
Cardiovascular · 27d
Cleared Nov 03, 2004
AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)
K042642
Ge Medical Systems Information Technologies
Cardiovascular · 37d