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
Cleared
Feb 19, 1998
MOBIMED SYSTEM, (PEGASUS AND POLARIS)
Ortivus Us, Inc.
Cardiovascular
168d
Cleared
Feb 06, 1998
DATEX-ENGSTROM NETWORK
Datex-Engstrom, Inc.
Cardiovascular
99d
Cleared
Jan 20, 1998
HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER
Hewlett-Packard Co.
Cardiovascular
46d
Cleared
Nov 13, 1997
IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM
Marquette Electronics, Inc.
Cardiovascular
177d
Cleared
Nov 06, 1997
(VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH
Data Critical Corporation
Cardiovascular
499d
Cleared
Oct 22, 1997
WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET
Marquette Electronics, Inc.
Cardiovascular
168d
Cleared
Oct 22, 1997
MDP2000 MEDICAL DATA PROCESSOR
Vidco, Inc.
Cardiovascular
78d
Cleared
Sep 19, 1997
DINAMAP MPS PORTABLE MONITOR
Johnson & Johnson Medical, Inc.
Cardiovascular
143d