Fingertip Pulse Oximeter

Oximeter

BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.

The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for Fingertip Pulse Oximeter.

Pre-market Notification Details

Device IDK151206
510k NumberK151206
Device Name:Fingertip Pulse Oximeter
ClassificationOximeter
Applicant BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. NO. 9 SHUANGYUAN ROAD, BADACHU HI-TECH ZONE SHIJINGSHAN DISTRICT Beijing,  CN 100041
ContactLei Chen
CorrespondentLei Chen
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. NO. 9 SHUANGYUAN ROAD, BADACHU HI-TECH ZONE SHIJINGSHAN DISTRICT Beijing,  CN 100041
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-06
Decision Date2015-08-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10875011000038 K151206 000

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