FDA 510(k) Application Details - K172366

Device Classification Name Oximeter

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510(K) Number K172366
Device Name Oximeter
Applicant Beijing Choice Electronic Technology Co., Ltd.
No.9 Shuangyuan road, Badachu Hi-tech Zone, Shijingshan Dist
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 08/04/2017
Decision Date 03/16/2018
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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