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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 K883103
Device Name EPICARDIA PC/FC
Applicant
Medicomp, Inc.
7845 Ellis Rd.
West Melbourne,  FL  32904
Applicant Contact RIFFE
Correspondent
Medicomp, Inc.
7845 Ellis Rd.
West Melbourne,  FL  32904
Correspondent Contact RIFFE
Regulation Number870.1025
Classification Product Code
DSI  
Date Received07/22/1988
Decision Date 09/22/1988
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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