Adhesive Electrodes

Electrode, Cutaneous

ShenZhen Quality Medical Technology Co.,Ltd

The following data is part of a premarket notification filed by Shenzhen Quality Medical Technology Co.,ltd with the FDA for Adhesive Electrodes.

Pre-market Notification Details

Device IDK171381
510k NumberK171381
Device Name:Adhesive Electrodes
ClassificationElectrode, Cutaneous
Applicant ShenZhen Quality Medical Technology Co.,Ltd 5/F, Plant C3, No.1, Nuclear Power Industrial Zone Guanlan Shijing Community Shenzhen,  CN
ContactGrace Zhao
CorrespondentJet Li
Guangzhou LETA Testing Technology Co., Ltd 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou,  CN
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-11
Decision Date2017-12-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860074002245 K171381 000
00810025923839 K171381 000
00810025923822 K171381 000
00850033118148 K171381 000
00850033118131 K171381 000

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