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FDA 510(k) Application Details - K150782
Device Classification Name
Stethoscope, Electronic
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510(K) Number
K150782
Device Name
Stethoscope, Electronic
Applicant
GI Logic Inc
909 East Green Street
Pasadena, CA 91106 US
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Contact
James Beeton
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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
03/25/2015
Decision Date
12/14/2015
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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