FDA 510(k) Application Details - K012770

Device Classification Name Oximeter

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510(K) Number K012770
Device Name Oximeter
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS, MA 01923 US
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Contact PENELOPE H GRECO
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 08/17/2001
Decision Date 07/23/2002
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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