FDA 510(k) Application Details - K051257

Device Classification Name Oximeter

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510(K) Number K051257
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 05/16/2005
Decision Date 12/22/2005
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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