FDA 510(k) Application Details - K060197

Device Classification Name Stethoscope, Electronic

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510(K) Number K060197
Device Name Stethoscope, Electronic
Applicant ZARGIS MEDICAL CORP.
2 RESEARCH WAY
PRINCETON, NJ 08540 US
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Contact JOHN KALLASSY
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 01/26/2006
Decision Date 03/29/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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