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
73–96 of 118
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 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
Cleared Nov 02, 2001
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX
K012531
Datex-Ohmeda
Cardiovascular · 88d
Cleared Jul 13, 2000
DATEX-OHMEDA NETWORK AND CENTRAL
K000647
Datex-Ohmeda, Inc.
Cardiovascular · 136d
Cleared Mar 28, 2000
IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM
K994430
General Electric Medical Systems Information Techn
Cardiovascular · 90d
Cleared Jan 14, 2000
ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841
K992749
Spacelabs Medical, Inc.
Cardiovascular · 151d
Cleared Nov 19, 1999
ALARMVIEW SYSTEM
K992848
Data Critical Corp.
Cardiovascular · 87d
Cleared Sep 20, 1999
STATVIEW SYSTEM
K990378
Data Critical Corp.
Cardiovascular · 224d
Cleared Aug 14, 1998
DINAMAP MPS SELECT PORTABLE MONITOR
K982342
Critikon Company, LLC
Cardiovascular · 39d
Cleared Mar 31, 1998
CARDIO-PAGER SYSTEM
K973527
Data Critical Corp.
Cardiovascular · 194d
Cleared Mar 12, 1998
TS2000 MEDICAL DEVICE MONITOR
K973640
Trincore Systems, Inc.
Cardiovascular · 169d