Jaijian Self-Adhesive Electrode

Electrode, Cutaneous

Wuxi Jiajian Medical Instrument Co., Ltd

The following data is part of a premarket notification filed by Wuxi Jiajian Medical Instrument Co., Ltd with the FDA for Jaijian Self-adhesive Electrode.

Pre-market Notification Details

Device IDK192568
510k NumberK192568
Device Name:Jaijian Self-Adhesive Electrode
ClassificationElectrode, Cutaneous
Applicant Wuxi Jiajian Medical Instrument Co., Ltd NO.35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi,  CN 214116
ContactCaihong Sun
CorrespondentCaihong Sun
Wuxi Jiajian Medical Instrument Co., Ltd NO.35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi,  CN 214116
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-18
Decision Date2021-02-03

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