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FDA 510(k) Application Details - K123148
Device Classification Name
Stethoscope, Electronic
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.1875
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Classification Product Code
DQD
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More FDA Info for this Product Code
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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