FDA 510(k) Application Details - K091972

Device Classification Name Stethoscope, Electronic

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510(K) Number K091972
Device Name Stethoscope, Electronic
Applicant STETHOSCOPE TECHNOLOGIES, INC
38 MILLER AVE
PMB 170
MILL VALLEY, CA 94941 US
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Contact DAVID STARK
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 07/01/2009
Decision Date 09/23/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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