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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K962473
Device Name (VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH
Applicant
Data Critical Corporation
15222 Del Amo Ave.
Tustin,  CA  92780
Applicant Contact RAY PIZINGER
Correspondent
Data Critical Corporation
15222 Del Amo Ave.
Tustin,  CA  92780
Correspondent Contact RAY PIZINGER
Regulation Number870.2300
Classification Product Code
MSX  
Date Received06/25/1996
Decision Date 11/06/1997
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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