Fingertip Pulse Oximeter MD300CG11/MD300CG51

Oximeter

BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.

The following data is part of a premarket notification filed by Beijing Choice Electronic Technology Co., Ltd. with the FDA for Fingertip Pulse Oximeter Md300cg11/md300cg51.

Pre-market Notification Details

Device IDK160268
510k NumberK160268
Device Name:Fingertip Pulse Oximeter MD300CG11/MD300CG51
ClassificationOximeter
Applicant BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. NO.9 SHUANGYUAN ROAD BADACHU HI-TECH ZONE, SHIJINGSHAN DISTRICT Beijing,  CN 100041
ContactLei Chen
CorrespondentLei Chen
BEIJING CHOICE ELECTRONIC TECHNOLOGY 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 Received2016-02-02
Decision Date2016-10-14
Summary:summary

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