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 Data Critical Corp., Datex-Ohmeda and Shenzhen Mindray Bio-Medical Electronics Co., Ltd..

120
Total
120
Cleared
133d
Avg days
1997
Since
120 devices
73–96 of 120
Cleared Sep 19, 2006
SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847
K062278
Spacelabs Medical, Inc.
Cardiovascular · 43d
Cleared Sep 14, 2006
BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE
K061932
Cardiopulmonary Corp.
Cardiovascular · 69d
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
LIFENET EXCHANGE SYSTEM
K052854
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
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
Cleared Jun 23, 2005
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
K051283
Cardiopulmonary Corp.
Cardiovascular · 37d
Cleared Nov 12, 2004
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS
K042845
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 28d
Cleared Oct 15, 2004
GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3
K042771
Datex-Ohmeda
Cardiovascular · 10d
Cleared May 12, 2004
MODIFICATION TO INFINITY EXPLORER
K040945
Draeger Medical Systems, Inc.
Cardiovascular · 30d
Cleared Nov 26, 2003
DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE
K033281
Datex-Ohmeda
Cardiovascular · 43d
Cleared Oct 29, 2003
DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE
K033078
Datex-Ohmeda
Cardiovascular · 30d
Cleared Sep 17, 2003
UNITY NETWORK PATIENT DATA SERVER
K032582
Ge Medical Systems Information Technologies
Cardiovascular · 27d
Cleared Aug 05, 2003
UNITY NETWORK IS PATIENT VIEWER
K032346
Ge Medical Systems Information Technologies
Cardiovascular · 6d
Cleared Mar 21, 2003
INFINITY EXPLORER
K030615
Siemens Medical Solutions USA, Inc.
Cardiovascular · 23d
Cleared Nov 04, 2002
DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE
K023497
Datex-Ohmeda
Cardiovascular · 17d
Cleared Aug 23, 2002
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02
K022507
Datex-Ohmeda
Cardiovascular · 24d
Cleared May 24, 2002
UNITY IS PATIENT VIEWER
K020661
General Electric Medical Systems Information Techn
Cardiovascular · 84d
Cleared Mar 20, 2002
PATIENTNET MONITORING SYSTEM
K020524
General Electric Medical Systems Information Techn
Cardiovascular · 29d
Cleared Feb 21, 2002
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
K020018
Cardiopulmonary Corp.
Cardiovascular · 49d
Cleared Jan 08, 2002
DATEX-OHMEDA S/5 WEB VIEWER
K013387
Datex-Ohmeda
Cardiovascular · 88d
Cleared Dec 11, 2001
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01
K013246
Datex-Ohmeda
Cardiovascular · 74d