FDA 510(k) Application Details - K092652

Device Classification Name Oximeter

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510(K) Number K092652
Device Name Oximeter
Applicant BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
BAILANGUYAN BLDG B 1127-1128
FUXING RD, A36
BEIJING 100039 CN
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Contact LEI CHEN
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 08/28/2009
Decision Date 01/08/2010
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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