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FDA 510(k) Application Details - K132405
Device Classification Name
Stethoscope, Electronic
More FDA Info for this Device
510(K) Number
K132405
Device Name
Stethoscope, Electronic
Applicant
RNK PRODUCTS, INC.
8247 Devereux Dr Ste 101
Melbourne, FL 32940 US
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Contact
CHARLES R ABBRUSCATO
Other 510(k) Applications for this Contact
Regulation Number
870.1875
More FDA Info for this Regulation Number
Classification Product Code
DQD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/02/2013
Decision Date
10/11/2013
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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