FDA 510(k) Application Details - K960614

Device Classification Name Oximeter

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510(K) Number K960614
Device Name Oximeter
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 DQA
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Date Received 02/13/1996
Decision Date 06/05/1996
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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