FDA 510(k) Application Details - K090493

Device Classification Name Stethoscope, Electronic

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510(K) Number K090493
Device Name Stethoscope, Electronic
Applicant ZARGIS MEDICAL CORP.
2 RESEARCH WAY, 1ST FLOOR
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 02/25/2009
Decision Date 08/07/2009
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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