FDA 510(k) Application Details - K072825

Device Classification Name Oximeter

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510(K) Number K072825
Device Name Oximeter
Applicant BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
SUITE 8D, ZHONGXIN ZHONGSHAN
NO19, LN999, ZHONG SHAN NAN ER
SHANGHAI 200030 CN
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Contact Diana Hong
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 10/02/2007
Decision Date 01/14/2008
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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