FDA 510(k) Application Details - K062605

Device Classification Name Oximeter

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510(K) Number K062605
Device Name Oximeter
Applicant PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER, MA 01810 US
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Contact RICH MCCLEARY
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 09/05/2006
Decision Date 11/09/2006
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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