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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 K864401
Device Name PLURIMUS CARDIAC EVALUATION SYSTEM
Applicant
Vivix Corp.
6410 Via Del Oro
San Jose,  CA  95119
Applicant Contact L. C BADAGLIACCA
Correspondent
Vivix Corp.
6410 Via Del Oro
San Jose,  CA  95119
Correspondent Contact L. C BADAGLIACCA
Regulation Number870.1025
Classification Product Code
DSI  
Date Received11/06/1986
Decision Date 03/03/1987
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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