FDA 510(k) Application Details - K993623

Device Classification Name Stethoscope, Electronic

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510(K) Number K993623
Device Name Stethoscope, Electronic
Applicant ALLEN MEDICAL INSTRUMENTS CORP.
505 SUPERIOR AVE.
NEWPORT BEACH, CA 92663 US
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Contact JUDITH ALLEN
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 10/26/1999
Decision Date 06/23/2000
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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