FDA 510(k) Application Details - K063752

Device Classification Name Oximeter

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510(K) Number K063752
Device Name Oximeter
Applicant NONIN MEDICAL, INC.
13700 1ST AVE. NORTH
PLYMOUTH, MN 55441-5443 US
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Contact LORI M ROTH
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 12/19/2006
Decision Date 05/04/2007
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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