Electrodes With Snap / Electrodes With Pigtail

Electrode, Cutaneous

Shenzhen Konmed Technology Co., Ltd

The following data is part of a premarket notification filed by Shenzhen Konmed Technology Co., Ltd with the FDA for Electrodes With Snap / Electrodes With Pigtail.

Pre-market Notification Details

Device IDK171722
510k NumberK171722
Device Name:Electrodes With Snap / Electrodes With Pigtail
ClassificationElectrode, Cutaneous
Applicant Shenzhen Konmed Technology Co., Ltd 703B, Haide Building A, Nanxin Road, Nanshan Shenzhen,  CN 518000
ContactTony Tony
CorrespondentCecilia Ceng
Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou,  CN 510006
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-12
Decision Date2018-01-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970935830161 K171722 000
06970935830154 K171722 000
06970935830116 K171722 000
06970935830109 K171722 000
06970935830093 K171722 000
06970935830086 K171722 000
06970935830079 K171722 000

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