JIAJIAN 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 Jiajian Self-adhesive Electrode.

Pre-market Notification Details

Device IDK090198
510k NumberK090198
Device Name:JIAJIAN SELF-ADHESIVE ELECTRODE
ClassificationElectrode, Cutaneous
Applicant WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. QINGHONG RD., EHU TOWN XISHAN DISTRICT Wuxi, Jiangsu,  CN 214116
ContactDoris Dong
CorrespondentDoris Dong
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. QINGHONG RD., EHU TOWN XISHAN DISTRICT Wuxi, Jiangsu,  CN 214116
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-01-27
Decision Date2009-06-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810011252301 K090198 000
10885914070762 K090198 000
10885914070755 K090198 000
20885914070745 K090198 000
20885914070738 K090198 000

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