FDA 510(k) Application Details - K964978

Device Classification Name Oximeter

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510(K) Number K964978
Device Name Oximeter
Applicant QUINTON, INC.
3303 MONTE VILLA PKWY.
BOTHELL, WA 98021-8906 US
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Contact MATTHEW HEDLUND
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 12/12/1996
Decision Date 05/21/1997
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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