FDA 510(k) Application Details - K103499

Device Classification Name Stethoscope, Electronic

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510(K) Number K103499
Device Name Stethoscope, Electronic
Applicant ACTIVE SIGNAL TECHNOLOGIES, INC.
11874 SOUTH EVELYN CIR.
HOUSTON, TX 77071 US
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Contact HARVEY KNAUSS
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 11/29/2010
Decision Date 03/31/2011
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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