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
217–240 of 425
Cleared Oct 10, 2003
VIEWPOINT TELEMETRY SYSTEM
K031760
Datascope Corp.
Cardiovascular · 126d
Cleared Oct 10, 2003
FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR
K032290
Fukuda Denshi USA, Inc.
Cardiovascular · 78d
Cleared Sep 09, 2003
SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX
K031849
Datascope Corp.
Cardiovascular · 85d
Cleared Aug 15, 2003
MODIFICATION TO: APEXPRO TELEMETRY SYSTEM
K032369
Ge Medical Systems Information Technologies
Cardiovascular · 14d
Cleared Jul 16, 2003
DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES
K031376
Ge Medical Systems Information Technologies
Cardiovascular · 76d
Cleared Jun 25, 2003
DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES
K031781
Datex-Ohmeda
Cardiovascular · 15d
Cleared Jun 06, 2003
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
K030738
Siemens Medical Solutions USA, Inc.
Cardiovascular · 88d
Cleared May 30, 2003
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1
K031403
Philips Medical Systems, Inc.
Cardiovascular · 25d
Cleared May 21, 2003
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE
K030812
Datex-Ohmeda
Cardiovascular · 68d
Cleared May 13, 2003
DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000
K022834
Ge Medical Systems Information Technologies
Cardiovascular · 260d
Cleared May 06, 2003
EK-PRO ARRHYTHMIA DETECTION ALGORITHM
K031320
Ge Medical Systems Information Technologies
Cardiovascular · 11d
Cleared Mar 21, 2003
MODIFICATION TO SOLAR 9500 INFORMATION MONITOR
K030575
Ge Medical Systems Information Technologies
Cardiovascular · 25d
Cleared Mar 12, 2003
PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL TECHNOLOGY AND M3185 OPT C41 WIRELESS BEDSIDE ADAPTR
K030038
Philips Medical Systems, Inc.
Cardiovascular · 65d
Cleared Mar 04, 2003
ANESTHESIA MONITOR
K030105
Nihon Kohden America, Inc.
Cardiovascular · 50d
Cleared Feb 26, 2003
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
K030431
Ge Medical Systems Information Technologies
Cardiovascular · 16d
Cleared Feb 11, 2003
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K030313
Siemens Medical Solutions USA, Inc.
Cardiovascular · 12d
Cleared Dec 18, 2002
SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM
K024108
Siemens Medical Solutions USA, Inc.
Cardiovascular · 5d
Cleared Dec 04, 2002
M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY
K023871
Philips Medical Systems
Cardiovascular · 14d
Cleared Nov 29, 2002
PHILIPS DRUG CALCULATOR SOFTWARE
K023674
Philips Medical Systems
Cardiovascular · 28d
Cleared Nov 19, 2002
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O
K023698
Philips Medical Systems
Cardiovascular · 15d
Cleared Nov 04, 2002
SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS
K023569
Siemens Medical Solutions USA, Inc.
Cardiovascular · 11d
Cleared Oct 24, 2002
CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES
K023475
Nihon Kohden America, Inc.
Cardiovascular · 8d
Cleared Oct 03, 2002
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE
K022485
Datex-Ohmeda
Cardiovascular · 66d
Cleared Sep 25, 2002
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER
K022889
Siemens Medical Solutions USA, Inc.
Cardiovascular · 26d