FDA 510(k) Application Details - K001306

Device Classification Name Stethoscope, Electronic

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510(K) Number K001306
Device Name Stethoscope, Electronic
Applicant ANDROMED, INC.
2310 BOUL ALFRED-NOBEL
ST.LAURENT, QUEBEC H4S 2A4 CA
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Contact JEAN DUMAS
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 04/25/2000
Decision Date 07/20/2000
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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