FDA 510(k) Application Details - K032230

Device Classification Name Stethoscope, Electronic

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510(K) Number K032230
Device Name Stethoscope, Electronic
Applicant THINKLABS INC.
30 NORTHPORT ROAD
SOUND BEACH, NY 11789 US
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Contact RICHARD LANZILLOTTO
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 07/21/2003
Decision Date 11/26/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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