FDA 510(k) Application Details - K001788

Device Classification Name Stethoscope, Electronic

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510(K) Number K001788
Device Name Stethoscope, Electronic
Applicant ERECORDS ENTERPRISES
801 YORK MILLS ROAD
SUITE 314
TORONTO CA
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Contact ED GOSS
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 06/13/2000
Decision Date 11/03/2000
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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