FDA 510(k) Application Details - K083892

Device Classification Name Oximeter

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510(K) Number K083892
Device Name Oximeter
Applicant CAS MEDICAL SYSTEMS, INC.
44 EAST INDUSTRIAL RD.
BRANFORD, CT 06405 US
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Contact RON JEFFREY
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 12/29/2008
Decision Date 03/19/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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