FDA 510(k) Application Details - K091224

Device Classification Name Oximeter, Tissue Saturation

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510(K) Number K091224
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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Date Received 04/27/2009
Decision Date 07/09/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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