Fingertip Pulse Oximeter

Oximeter

XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD

The following data is part of a premarket notification filed by Xuzhou Yongkang Electronic Science Technology Co., Ltd with the FDA for Fingertip Pulse Oximeter.

Pre-market Notification Details

Device IDK161938
510k NumberK161938
Device Name:Fingertip Pulse Oximeter
ClassificationOximeter
Applicant XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD 4F BUILDING C8, 40 JINGSHAN ROAD, ECONONIC AND TECHNOLGICAL DEVELOPMENT ZONE Xuzhou,  CN 102628
ContactYanli Li
CorrespondentRay Wang
BEIJING BELIEVE TECHNOLOGY SERVICE CO., LTD. 5-1206, BUILD 332, DAFANGJU, NO.25 BANBIDIAN RD. Li Yuan Town, Tongzhou District, Beijing,  CN 101121
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-14
Decision Date2017-05-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06921745200026 K161938 000

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