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
193–216 of 425
Cleared Oct 06, 2004
INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5
K042656
Draeger Medical Systems, Inc.
Cardiovascular · 8d
Cleared Jul 28, 2004
DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES
K041772
Datex-Ohmeda
Cardiovascular · 27d
Cleared Jul 23, 2004
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE
K041790
Datex-Ohmeda
Cardiovascular · 21d
Cleared Jul 21, 2004
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN
K041741
Philips Medical Systems, Inc.
Cardiovascular · 23d
Cleared Jun 04, 2004
PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS
K041235
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 24d
Cleared Jun 03, 2004
FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM
K033711
Fukuda Denshi USA, Inc.
Cardiovascular · 190d
Cleared Jun 03, 2004
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
K040458
Ge Medical Systems Information Technologies
Cardiovascular · 101d
Cleared Jun 01, 2004
CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES
K040395
Nihon Kohden America, Inc.
Cardiovascular · 105d
Cleared May 26, 2004
FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR
K040246
Fukuda Denshi USA, Inc.
Cardiovascular · 113d
Cleared May 14, 2004
INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL
K033957
Draeger Medical Systems, Inc.
Cardiovascular · 144d
Cleared May 12, 2004
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN
K040955
Philips Medical Systems, Inc.
Cardiovascular · 29d
Cleared May 12, 2004
INFINITY GAMMA
K041087
Draeger Medical Systems, Inc.
Cardiovascular · 16d
Cleared Mar 22, 2004
INFINITY MODULAR MONITORS VF4 MODIFICATIONS
K033694
Draeger Medical Systems, Inc.
Cardiovascular · 119d
Cleared Mar 03, 2004
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II
K040357
Philips Medical Systems, Inc.
Cardiovascular · 19d
Cleared Mar 01, 2004
PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50
K040304
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 21d
Cleared Feb 26, 2004
ENVOY PATIENT MONITOR
K030722
Mennen Medical, Inc.
Cardiovascular · 356d
Cleared Jan 15, 2004
SOLAR 9500 INFORMATION MONITOR
K033964
Ge Medical Systems Information Technologies
Cardiovascular · 24d
Cleared Dec 11, 2003
INFINITY GAMMAXL
K033600
Draeger Medical Systems, Inc.
Cardiovascular · 27d
Cleared Dec 04, 2003
POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR
K031124
Datex-Ohmeda, Inc.
Cardiovascular · 240d
Cleared Nov 25, 2003
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO
K031340
Siemens Medical Solutions USA, Inc.
Cardiovascular · 211d
Cleared Nov 24, 2003
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
K033492
Ge Medical Systems Information Technologies
Cardiovascular · 20d
Cleared Nov 21, 2003
PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER
K033444
Philips Medical Systems
Cardiovascular · 23d
Cleared Nov 12, 2003
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
K033304
Ge Medical Systems Information Technologies
Cardiovascular · 29d
Cleared Nov 06, 2003
APEXPRO FH TELEMETRY SYSTEM
K033365
Ge Medical Systems Information Technologies
Cardiovascular · 16d