FDA 510(k) Application Details - K963678

Device Classification Name Stethoscope, Electronic

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510(K) Number K963678
Device Name Stethoscope, Electronic
Applicant AMERICAN TELECARE, INC.
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004-1109 US
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Contact GERARD J PRUD'HOMME, ESQ.
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 09/13/1996
Decision Date 02/24/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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