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FDA 510(k) Application Details - K082327
Device Classification Name
Oximeter, Tissue Saturation
More FDA Info for this Device
510(K) Number
K082327
Device Name
Oximeter, Tissue Saturation
Applicant
SOMANETICS CORP.
1653 EAST MAPLE RD.
TROY, MI 48083-4208 US
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Contact
RONALD A WIDMAN
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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
08/14/2008
Decision Date
04/03/2009
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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