FDA 510(k) Application Details - K021087

Device Classification Name Stethoscope, Electronic

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510(K) Number K021087
Device Name Stethoscope, Electronic
Applicant ERECORDS LIMITED
801 YORK MILLS ROAD
SUITE 314
TORONTO M3B 1X7 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 04/03/2002
Decision Date 10/11/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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