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FDA 510(k) Application Details - K211068
Device Classification Name
Stethoscope, Electronic
More FDA Info for this Device
510(K) Number
K211068
Device Name
Stethoscope, Electronic
Applicant
Entac Medical Inc.
680 Oakleaf Office Lane, Suite 201
Memphis, TN 38117 US
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Contact
Buddy Lyons
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Regulation Number
870.1875
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Classification Product Code
DQD
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More FDA Info for this Product Code
Date Received
04/12/2021
Decision Date
08/04/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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