Ennova Self-adhesive Electrode

Electrode, Cutaneous

Suzhou Ennova Electronics Technology Co.,Ltd

The following data is part of a premarket notification filed by Suzhou Ennova Electronics Technology Co.,ltd with the FDA for Ennova Self-adhesive Electrode.

Pre-market Notification Details

Device IDK152648
510k NumberK152648
Device Name:Ennova Self-adhesive Electrode
ClassificationElectrode, Cutaneous
Applicant Suzhou Ennova Electronics Technology Co.,Ltd Jinsigang Industrial Park, Guoxiang, Wuzhong District, Suzhou,  CN 215124
ContactN/a N/a
CorrespondentDoris Dong
SHANGHAI CV TECHNOLOGY CO., LTD ROOM 1706, NO.128 SONGLE RD., SONGJIANG AREA Shanghai,  CN 201600
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-16
Decision Date2016-02-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
16973265920080 K152648 000

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