FDA 510(k) Application Details - K012706

Device Classification Name Oximeter

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510(K) Number K012706
Device Name Oximeter
Applicant IMAGYN MEDICAL TECHNOLOGIES, INC.
1730 PENNSYLVANIA AVE., NW
WASHINGTON, DC 20006 US
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Contact SANDRA COHEN KALTER
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 08/14/2001
Decision Date 03/07/2003
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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