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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 K882119
Device Name TELSTETH TELEMETRIC STETHOSCOPE(TM)
Applicant
Quantsonics, Inc.
P.O. Box 786
Harrison,  NY  10528
Applicant Contact PETER M DERRICO
Correspondent
Quantsonics, Inc.
P.O. Box 786
Harrison,  NY  10528
Correspondent Contact PETER M DERRICO
Regulation Number870.2920
Classification Product Code
DXH  
Date Received05/19/1988
Decision Date 08/08/1988
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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