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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K945638
Device Name TELPHONIC STETHOSCOPE
Applicant
American Telecare, Inc.
7680 Golden Triangle Dr.
Eden Prairie,  MN  55344
Applicant Contact CHARLES R ABBRUSCATO
Correspondent
American Telecare, Inc.
7680 Golden Triangle Dr.
Eden Prairie,  MN  55344
Correspondent Contact CHARLES R ABBRUSCATO
Regulation Number870.1875
Classification Product Code
DQD  
Date Received11/16/1994
Decision Date 05/17/1995
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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