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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oximeter
510(k) Number K161938
Device Name Fingertip Pulse Oximeter
Applicant
XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD
4F BUILDING C8, 40 JINGSHAN ROAD,
ECONONIC AND TECHNOLGICAL DEVELOPMENT ZONE
XUZHOU,  CN 102628
Applicant Contact YANLI LI
Correspondent
BEIJING BELIEVE TECHNOLOGY SERVICE CO., LTD.
5-1206, BUILD 332, DAFANGJU, NO.25 BANBIDIAN RD.
LI YUAN TOWN, TONGZHOU DISTRICT, BEIJING,  CN 101121
Correspondent Contact RAY WANG
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/14/2016
Decision Date 05/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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