FDA 510(k) Application Details - K133090

Device Classification Name Oximeter

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510(K) Number K133090
Device Name Oximeter
Applicant DELBIO INCORPORATION
4405 CUSHING PKWY.
FREMONT CITY, CA 94538 US
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Contact ERICA LI
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 09/30/2013
Decision Date 02/28/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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