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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K853209
Device Name COMPAS 1
Applicant
Cardiac Care Units, Inc.
6911 Hayvenhurst Ave.
Van Nuys,  CA  91406
Applicant Contact THOMAS M CURRAN
Correspondent
Cardiac Care Units, Inc.
6911 Hayvenhurst Ave.
Van Nuys,  CA  91406
Correspondent Contact THOMAS M CURRAN
Regulation Number870.1025
Classification Product Code
DSI  
Date Received07/31/1985
Decision Date 11/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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