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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 K864293
Device Name HEART TRACK
Applicant
Cardio Telemetric Systems, Inc.
10250 Alliance Rd.
P.O. Box 42621
Cincinnati,  OH  45242
Applicant Contact THOMAS SHOUP
Correspondent
Cardio Telemetric Systems, Inc.
10250 Alliance Rd.
P.O. Box 42621
Cincinnati,  OH  45242
Correspondent Contact THOMAS SHOUP
Regulation Number870.2920
Classification Product Code
DXH  
Date Received10/31/1986
Decision Date 03/23/1987
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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