FDA 510(k) Application Details - K062481

Device Classification Name Stethoscope, Electronic

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510(K) Number K062481
Device Name Stethoscope, Electronic
Applicant PISHON HIGH TECH CO., LTD.
P.O. BOX 7007
DEERFIELD, IL 60015 US
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Contact DANIEL KAMM
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 08/24/2006
Decision Date 10/16/2006
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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