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
Cleared
Sep 19, 2006
SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847
Spacelabs Medical, Inc.
Cardiovascular
43d
Cleared
Sep 14, 2006
BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE
Cardiopulmonary Corp.
Cardiovascular
69d
Cleared
Aug 11, 2006
WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE
Ge Healthcare
Cardiovascular
28d
Cleared
Apr 04, 2006
MODIFICATION TO INFINITY EXPLORER
Draeger Medical Systems, Inc.
Cardiovascular
62d
Cleared
Jan 20, 2006
LIFENET EXCHANGE SYSTEM
Medtronic Emergency Response Systems, Inc.
Cardiovascular
101d
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
Ge Healthcare
Cardiovascular
88d
Cleared
Dec 29, 2005
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3
Ge Healthcare
Cardiovascular
66d
Cleared
Jul 19, 2005
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION
Ge Healthcare
Cardiovascular
29d
Cleared
Jun 23, 2005
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
Cardiopulmonary Corp.
Cardiovascular
37d
Cleared
Nov 12, 2004
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS
Philips Medizin Systeme Boblingen GmbH
Cardiovascular
28d
Cleared
Oct 15, 2004
GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3
Datex-Ohmeda
Cardiovascular
10d
Cleared
May 12, 2004
MODIFICATION TO INFINITY EXPLORER
Draeger Medical Systems, Inc.
Cardiovascular
30d
Cleared
Nov 26, 2003
DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE
Datex-Ohmeda
Cardiovascular
43d
Cleared
Oct 29, 2003
DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE
Datex-Ohmeda
Cardiovascular
30d
Cleared
Sep 17, 2003
UNITY NETWORK PATIENT DATA SERVER
Ge Medical Systems Information Technologies
Cardiovascular
27d
Cleared
Aug 05, 2003
UNITY NETWORK IS PATIENT VIEWER
Ge Medical Systems Information Technologies
Cardiovascular
6d
Cleared
Mar 21, 2003
INFINITY EXPLORER
Siemens Medical Solutions USA, Inc.
Cardiovascular
23d
Cleared
Nov 04, 2002
DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE
Datex-Ohmeda
Cardiovascular
17d
Cleared
Aug 23, 2002
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02
Datex-Ohmeda
Cardiovascular
24d
Cleared
May 24, 2002
UNITY IS PATIENT VIEWER
General Electric Medical Systems Information Techn
Cardiovascular
84d
Cleared
Mar 20, 2002
PATIENTNET MONITORING SYSTEM
General Electric Medical Systems Information Techn
Cardiovascular
29d
Cleared
Feb 21, 2002
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
Cardiopulmonary Corp.
Cardiovascular
49d
Cleared
Jan 08, 2002
DATEX-OHMEDA S/5 WEB VIEWER
Datex-Ohmeda
Cardiovascular
88d
Cleared
Dec 11, 2001
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01
Datex-Ohmeda
Cardiovascular
74d