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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 K880615
Device Name AMBULATORY ECG DIGITAL MONITOR MODEL: TD-30
Applicant
Cardiotechnics, Inc.
Post Office Box 2335
Big Spring,  TX  79721
Applicant Contact HARROL G JONES
Correspondent
Cardiotechnics, Inc.
Post Office Box 2335
Big Spring,  TX  79721
Correspondent Contact HARROL G JONES
Regulation Number870.2920
Classification Product Code
DXH  
Date Received02/16/1988
Decision Date 05/13/1988
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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