FDA 510(k) Application Details - K053381

Device Classification Name Oximeter

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510(K) Number K053381
Device Name Oximeter
Applicant WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS, NY 13153-0220 US
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Contact CHRIS KLACZYK
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 12/05/2005
Decision Date 06/15/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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