FDA 510(k) Application Details - K033715

Device Classification Name Oximeter

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510(K) Number K033715
Device Name Oximeter
Applicant PHILIPS MEDICAL SYSTEMS, INC.
3000 MINUTEMAN RD.
ANDOVER, MA 01810 US
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Contact DAVID OSBORN
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 11/26/2003
Decision Date 02/13/2004
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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