Self-adhesive Electrode

Electrode, Cutaneous

Guangdong Comytens Medical Technology Co., Ltd

The following data is part of a premarket notification filed by Guangdong Comytens Medical Technology Co., Ltd with the FDA for Self-adhesive Electrode.

Pre-market Notification Details

Device IDK222453
510k NumberK222453
Device Name:Self-adhesive Electrode
ClassificationElectrode, Cutaneous
Applicant Guangdong Comytens Medical Technology Co., Ltd Building A-102, No. 24, Jiangjunmao Industriual Zone Wulian, Longgang District Shenzhen,  CN 518116
ContactMr. Deng Jiuzhen
CorrespondentMr. Amos Zou
Guangdong Comytens Medical Technology Co., Ltd Building A-102, No. 24, Jiangjunmao Industrial Zone Wulian, Longgang District Shenzhen,  CN 518116
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-15
Decision Date2022-11-04

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