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FDA 510(k) Application Details - K123700
Device Classification Name
Oximeter, Tissue Saturation
More FDA Info for this Device
510(K) Number
K123700
Device Name
Oximeter, Tissue Saturation
Applicant
CAS MEDICAL SYSTEMS, INC.
44 EAST INDUSTRIAL RD.
BRANFORD, CT 06405 US
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Contact
RON JEFFREY
Other 510(k) Applications for this Contact
Regulation Number
870.2700
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Classification Product Code
MUD
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More FDA Info for this Product Code
Date Received
12/03/2012
Decision Date
04/11/2013
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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