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
Cleared
May 21, 2020
BeneVision Central Monitoring System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular
167d
Cleared
May 11, 2020
Critical Alert CommonPath Enterprise
Critical Alert
Cardiovascular
193d
Cleared
Jul 12, 2019
Wearable Device, Wearable Package
Current Health , Ltd.
Cardiovascular
60d
Cleared
Apr 26, 2019
Philips IntelliVue XDS Software
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular
214d
Cleared
Mar 27, 2019
Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub
Current Health , Ltd.
Cardiovascular
70d
Cleared
Mar 13, 2019
BeneVision Central Monitoring System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular
113d
Cleared
Nov 23, 2018
Digistat Smart Central
Ascom Ums Srl Unipersonale
Cardiovascular
280d
Cleared
Nov 14, 2018
Wearable Device
Snap40, Ltd.
Cardiovascular
58d
Cleared
Apr 03, 2018
Unite Connect for Clinical Systems
Ascom (Sweden) AB
Cardiovascular
29d
Cleared
Mar 14, 2018
Athena GTX Device Management Suite (ADMS) Software
Athena Gtx
Cardiovascular
163d
Cleared
Aug 03, 2017
eCareManager 4.1
Visicu, Inc.
Cardiovascular
90d
Cleared
Apr 20, 2017
BeneVision Central Monitoring System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular
213d
Cleared
Sep 30, 2016
eCareManager 4.0.1
Visicu, Inc.
Cardiovascular
333d
Cleared
Sep 19, 2016
AirStrip RPM
Airstrip Technologies, Inc.
Cardiovascular
174d
Cleared
Jun 24, 2016
CareEvent inclusive of the CareEvent Mobile Application accessory
Philips Medical Systems
Cardiovascular
60d
Cleared
Dec 21, 2015
Cerner CareAware Event Management
Cerner Corporation
Cardiovascular
182d
Cleared
Aug 31, 2015
EarlySense Central Display Station (CDS)
Earlysense, Ltd.
Cardiovascular
138d
Cleared
Jul 06, 2015
Hypervisor IX Monitoring System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular
117d
Cleared
Jan 30, 2015
VECTRAPLEX CMS
Vectracor, Inc.
Cardiovascular
302d
Cleared
Jan 15, 2015
CareEvent
Philips Medical Systems
Cardiovascular
98d
Cleared
Dec 12, 2014
INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION
Draeger Medical Systems, Inc.
Cardiovascular
165d
Cleared
Dec 03, 2014
M3290B Philips IntelliVue Information Center iX
Philips Medical Systems
Cardiovascular
40d
Cleared
Jul 01, 2014
HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016)
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
Cardiovascular
365d
Cleared
Nov 20, 2013
ISIRONA MAGELLAN
Isirona, LLC
Cardiovascular
250d