FDA 510(k) Application Details - K122046

Device Classification Name Oximeter

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510(K) Number K122046
Device Name Oximeter
Applicant BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
NO. 9 SHUANGYUAN RD.
SHIJINGSHAN DISTRICT
BEIJING 100041 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 07/12/2012
Decision Date 02/04/2013
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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