FDA 510(k) Application Details - K142888

Device Classification Name Oximeter

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510(K) Number K142888
Device Name Oximeter
Applicant BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
No.9 Shuangyuan Road, Badachu Hi-tech Zone,
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 10/02/2014
Decision Date 02/20/2015
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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