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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K981119
Device Name CARDIOPAL MODEL NUMBER PM20
Applicant
Medicomp, Inc.
7845 Ellis Rd.
West Melbourne,  FL  32904
Applicant Contact JOSEPHUS RIFFE
Correspondent
Medicomp, Inc.
7845 Ellis Rd.
West Melbourne,  FL  32904
Correspondent Contact JOSEPHUS RIFFE
Regulation Number870.2920
Classification Product Code
DXH  
Date Received03/27/1998
Decision Date 10/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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