MSX · Class II · 21 CFR 870.2300

FDA Product Code MSX: System, Network And Communication, Physiological Monitors

Centralized physiological monitoring networks improve patient safety across hospital units. FDA product code MSX covers network and communication systems for physiological monitoring data.

These systems aggregate and transmit vital sign data from bedside monitors to central nursing stations, electronic health records, and alarm notification systems, enabling surveillance of multiple patients simultaneously and integration of monitoring data into clinical workflows.

MSX devices are Class II medical devices, regulated under 21 CFR 870.2300 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Data Critical Corp., Datex-Ohmeda and Shenzhen Mindray Bio-Medical Electronics Co., Ltd..

120
Total
120
Cleared
133d
Avg days
1997
Since
120 devices
49–72 of 120
Cleared Jul 01, 2014
HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016)
K132036
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
Cardiovascular · 365d
Cleared Nov 20, 2013
ISIRONA MAGELLAN
K130707
Isirona, LLC
Cardiovascular · 250d
Cleared Jul 11, 2013
CLINICAL ALERT NOTIFICATION
K130339
Extension , Inc.
Cardiovascular · 150d
Cleared Nov 20, 2012
AIRSTRIP RPM FOR LIFENET CONSULT
K121712
Airstrip Technologies, Inc.
Cardiovascular · 162d
Cleared Nov 20, 2012
ZOLL RESCUENET 12-LEAD
K121865
ZOLL Medical Corporation
Cardiovascular · 147d
Cleared Sep 10, 2012
EARLYSENSE CENTRAL DISPLAY SYSTEM
K121885
Earlysense, Ltd.
Cardiovascular · 74d
Cleared Feb 01, 2012
CONNEXALL SUITE OF SOFTWARE PRODUCTS
K112650
Connexall USA, Inc.
Cardiovascular · 142d
Cleared Nov 04, 2011
M VISUM ALERT ALARM MANAGEMENT SYSTEM
K112282
Mvisum, Inc.
Cardiovascular · 87d
Cleared Oct 27, 2011
ZOLL RESCUENETLINK
K111296
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 171d
Cleared Sep 13, 2011
AMCOM COMMTECH MESSENGER
K112047
Amcom Software,Inc.
Cardiovascular · 57d
Cleared Jul 05, 2011
ASCOM MOBILE MONITORING GATEWAY (MMG)
K111215
Ascom (Sweden) AB
Cardiovascular · 64d
Cleared Apr 19, 2011
EVERON CENTRAL DISPLAY STATION (CDS)
K110521
Earlysense, Ltd.
Cardiovascular · 55d
Cleared Feb 23, 2011
ASCOM CLINICALCONNEX CARDIOMAX
K103634
Ascom (Us), Inc.
Cardiovascular · 72d
Cleared Jan 04, 2011
INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00
K102974
Philips Medical Systems
Cardiovascular · 90d
Cleared Nov 05, 2010
LIFENET SYSTEM
K102757
Physio-Control, Inc.
Cardiovascular · 43d
Cleared Aug 06, 2010
EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0
K100376
Earlysense, Ltd.
Cardiovascular · 175d
Cleared Jan 12, 2010
LIFENET SYSTEM
K093925
Physio-Control, Inc.
Cardiovascular · 21d
Cleared Nov 13, 2009
PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441
K091176
Philips Medical Systems
Cardiovascular · 205d
Cleared Apr 03, 2008
HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS)
K080192
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 69d
Cleared Sep 07, 2007
PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521
K071391
Philips Medical Systems, Inc.
Cardiovascular · 112d
Cleared Jun 08, 2007
MASIMO PATIENT SAFETY NET
K071047
Masimo Corporation
Cardiovascular · 56d
Cleared Mar 23, 2007
LINK TO ACUITY CLINICIAN NOTIFIER
K070204
Welch Allyn Protocol, Inc.
Cardiovascular · 60d
Cleared Mar 13, 2007
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02
K070421
Ge Healthcare
Cardiovascular · 28d
Cleared Oct 16, 2006
PMP4 APPLICATION
K061428
Card Guard Scientific Survival , Ltd.
Cardiovascular · 146d