FDA 510(k) Application Details - K132405

Device Classification Name Stethoscope, Electronic

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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
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Regulation Number 870.1875

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Classification Product Code DQD
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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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