Panels › Cardiovascular › Product code MSX · Class 2

System, Network And Communication, Physiological Monitors

Regulation 870.2300

5510(k)s in 12 months (121 all time)

3recalls in 12 months (23 all time)

22recalls that name a 510(k)

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Top companies in MSX

Company	510(k)s	Recalls
Data Critical Corp.	9	0
Datex-Ohmeda	9	0
GE Healthcare	5	4
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	7	0
Visicu, Inc.	5	2
Philips Medical Systems	6	0
Current Health	5	0
Draeger Medical Systems, Inc.	5	0
Earlysense, Ltd.	4	0
Mindray DS USA, Inc. dba Mindray North America	0	4

Decided	510(k)	Device and applicant	Code
Jul 24, 2001	K012005	MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM Data Critical Corp.	MSX
Jul 24, 2001	K011999	MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM Data Critical Corp.	MSX
Apr 5, 2001	K010912	ALARMVIEW WIRELESS DATA NETWORK SYSTEM Data Critical Corp.	MSX
Mar 7, 2001	K003998	FLEXVIEW CLINICAL MONITORING SYSTEM Data Critical Corp.	MSX
Oct 27, 2000	K001972	ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK Visicu, Inc.	MSX
Jul 13, 2000	K000647	DATEX-OHMEDA NETWORK AND CENTRAL Datex-Ohmeda, Inc.	MSX
Mar 28, 2000	K994430	IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM General Electric Medical Systems Information Techn	MSX
Jan 14, 2000	K992749	ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841 Spacelabs Medical, Inc.	MSX
Nov 19, 1999	K992848	ALARMVIEW SYSTEM Data Critical Corp.	MSX
Sep 20, 1999	K990378	STATVIEW SYSTEM Data Critical Corp.	MSX
Aug 14, 1998	K982342	DINAMAP MPS SELECT PORTABLE MONITOR Critikon Company, LLC	MSX
Mar 31, 1998	K973527	CARDIO-PAGER SYSTEM Data Critical Corp.	MSX
Mar 12, 1998	K973640	TS2000 MEDICAL DEVICE MONITOR Trincore Systems, Inc.	MSX
Feb 19, 1998	K973318	MOBIMED SYSTEM, (PEGASUS AND POLARIS) Ortivus Us, Inc.	MSX
Feb 6, 1998	K974101	DATEX-ENGSTROM NETWORK Datex-Engstrom, Inc.	MSX
Jan 20, 1998	K974567	HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER Hewlett-Packard Co.	MSX
Nov 13, 1997	K971868	IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM Marquette Electronics, Inc.	MSX
Nov 6, 1997	K962473	(VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH Data Critical Corporation	MSX
Oct 22, 1997	K972880	MDP2000 MEDICAL DATA PROCESSOR Vidco, Inc.	MSX
Oct 22, 1997	K971683	WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET Marquette Electronics, Inc.	MSX
Sep 19, 1997	K971569	DINAMAP MPS PORTABLE MONITOR Johnson & Johnson Medical, Inc.	MSX

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