FDA 510(k) Application Details - K162089

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

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510(K) Number K162089
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant BEIJING CHOICE ELECTRONIC TECHNOLOGY 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 870.1130

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Classification Product Code DXN
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Date Received 07/28/2016
Decision Date 02/10/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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