FDA 510(k) Application Details - K123148

Device Classification Name Stethoscope, Electronic

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510(K) Number K123148
Device Name Stethoscope, Electronic
Applicant PARACE LLC
PO BOX 171
YORKTOWN HEIGHTS, NY 10598 US
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Contact VANDETTE CARTER
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 10/05/2012
Decision Date 11/19/2013
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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