FDA 510(k) Application Details - K081937

Device Classification Name Oximeter

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510(K) Number K081937
Device Name Oximeter
Applicant PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH
HEWLETT-PACKARD STR.2
BOEBLINGEN D-71034 DE
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Contact JENS-PETER SEHER
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 07/07/2008
Decision Date 08/29/2008
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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