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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 K843513
Device Name EPICARDIA, PC
Applicant
Medicomp, Inc.
1250 W. Nasa Blvd.
Milbourne,  FL  32901
Applicant Contact CHARLES C BUSBY
Correspondent
Medicomp, Inc.
1250 W. Nasa Blvd.
Milbourne,  FL  32901
Correspondent Contact CHARLES C BUSBY
Regulation Number870.1025
Classification Product Code
DSI  
Date Received09/06/1984
Decision Date 10/22/1984
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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