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
25–48 of 118
Cleared May 21, 2020
BeneVision Central Monitoring System
K193391
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 167d
Cleared May 11, 2020
Critical Alert CommonPath Enterprise
K193043
Critical Alert
Cardiovascular · 193d
Cleared Jul 12, 2019
Wearable Device, Wearable Package
K191272
Current Health , Ltd.
Cardiovascular · 60d
Cleared Apr 26, 2019
Philips IntelliVue XDS Software
K182637
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
K190073
Current Health , Ltd.
Cardiovascular · 70d
Cleared Mar 13, 2019
BeneVision Central Monitoring System
K183238
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 113d
Cleared Nov 23, 2018
Digistat Smart Central
K180430
Ascom Ums Srl Unipersonale
Cardiovascular · 280d
Cleared Nov 14, 2018
Wearable Device
K182543
Snap40, Ltd.
Cardiovascular · 58d
Cleared Apr 03, 2018
Unite Connect for Clinical Systems
K180566
Ascom (Sweden) AB
Cardiovascular · 29d
Cleared Mar 14, 2018
Athena GTX Device Management Suite (ADMS) Software
K173203
Athena Gtx
Cardiovascular · 163d
Cleared Aug 03, 2017
eCareManager 4.1
K171322
Visicu, Inc.
Cardiovascular · 90d
Cleared Apr 20, 2017
BeneVision Central Monitoring System
K162607
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 213d
Cleared Sep 30, 2016
eCareManager 4.0.1
K153156
Visicu, Inc.
Cardiovascular · 333d
Cleared Sep 19, 2016
AirStrip RPM
K160862
Airstrip Technologies, Inc.
Cardiovascular · 174d
Cleared Jun 24, 2016
CareEvent inclusive of the CareEvent Mobile Application accessory
K161164
Philips Medical Systems
Cardiovascular · 60d
Cleared Dec 21, 2015
Cerner CareAware Event Management
K151672
Cerner Corporation
Cardiovascular · 182d
Cleared Aug 31, 2015
EarlySense Central Display Station (CDS)
K151006
Earlysense, Ltd.
Cardiovascular · 138d
Cleared Jul 06, 2015
Hypervisor IX Monitoring System
K150632
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 117d
Cleared Jan 30, 2015
VECTRAPLEX CMS
K140852
Vectracor, Inc.
Cardiovascular · 302d
Cleared Jan 15, 2015
CareEvent
K142935
Philips Medical Systems
Cardiovascular · 98d
Cleared Dec 12, 2014
INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION
K141756
Draeger Medical Systems, Inc.
Cardiovascular · 165d
Cleared Dec 03, 2014
M3290B Philips IntelliVue Information Center iX
K143057
Philips Medical Systems
Cardiovascular · 40d
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