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 Datex-Ohmeda, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and Draeger Medical Systems, Inc..

118
Total
118
Cleared
132d
Avg days
1997
Since
118 devices
49–72 of 118
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 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 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
Cleared Sep 19, 2006
SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847
K062278
Spacelabs Medical, Inc.
Cardiovascular · 43d
Cleared Aug 11, 2006
WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE
K061994
Ge Healthcare
Cardiovascular · 28d
Cleared Apr 04, 2006
MODIFICATION TO INFINITY EXPLORER
K060254
Draeger Medical Systems, Inc.
Cardiovascular · 62d
Cleared Jan 20, 2006
DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE
K052975
Ge Healthcare
Cardiovascular · 88d
Cleared Dec 29, 2005
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3
K052972
Ge Healthcare
Cardiovascular · 66d
Cleared Jul 19, 2005
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION
K051634
Ge Healthcare
Cardiovascular · 29d