FDA 510(k) Application Details - K961301

Device Classification Name Stethoscope, Electronic

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510(K) Number K961301
Device Name Stethoscope, Electronic
Applicant DELPHI CONSULTING GROUP
11874 SOUTH EVELYN CIRCLE
HOUSTON, TX 77071 US
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Contact J. HARVEY KNAUSS
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 04/04/1996
Decision Date 06/11/1996
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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