FDA 510(k) Application Details - K993637

Device Classification Name Oximeter

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510(K) Number K993637
Device Name Oximeter
Applicant NELLCOR PURITAN BENNETT, INC.
2200 FARADAY AVE.
CARLSBAD, CA 92008-7208 US
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Contact DAVID A.C. GREEN
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 10/28/1999
Decision Date 11/24/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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