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 Philips Medical Systems.

117
Total
117
Cleared
131d
Avg days
1997
Since
117 devices
25–48 of 117
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 Apr 20, 2017
BeneVision Central Monitoring System
K162607
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 213d
Cleared Jun 24, 2016
CareEvent inclusive of the CareEvent Mobile Application accessory
K161164
Philips Medical Systems
Cardiovascular · 60d
Cleared Jul 06, 2015
Hypervisor IX Monitoring System
K150632
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 117d
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 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