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 IDK130947
510k NumberK130947
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 Received2013-04-04
Decision Date2013-10-03
Summary:summary

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