FDA 510(k) Application Details - K083787

Device Classification Name Oximeter

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510(K) Number K083787
Device Name Oximeter
Applicant SMITHS MEDICAL PM, INC.
N7 W22025 JOHNSON DR.
WAUKESHA, WI 53186-1856 US
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Contact DONALD ALEXANDER
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 12/19/2008
Decision Date 04/15/2009
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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