TOP-RANK ADHESIVE ELECTRODE

Electrode, Cutaneous

TOP-RANK HEALTH CARE EQUIPMENT CO., LTD.

The following data is part of a premarket notification filed by Top-rank Health Care Equipment Co., Ltd. with the FDA for Top-rank Adhesive Electrode.

Pre-market Notification Details

Device IDK070612
510k NumberK070612
Device Name:TOP-RANK ADHESIVE ELECTRODE
ClassificationElectrode, Cutaneous
Applicant TOP-RANK HEALTH CARE EQUIPMENT CO., LTD. DONGGUAN ST. Shangyu City,  CN 312352
ContactUwe Degenhardt
CorrespondentLaura Danielson
TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton,  MN  55112 -1891
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-03-05
Decision Date2007-05-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.