ADHESIVE ELECTRODES

Electrode, Cutaneous

RENO MEDICAL LIMITED

The following data is part of a premarket notification filed by Reno Medical Limited with the FDA for Adhesive Electrodes.

Pre-market Notification Details

Device IDK102842
510k NumberK102842
Device Name:ADHESIVE ELECTRODES
ClassificationElectrode, Cutaneous
Applicant RENO MEDICAL LIMITED P.O. BOX 237-023 Shanghai,  CN 200237
ContactDiana Hong
CorrespondentDiana Hong
RENO MEDICAL LIMITED P.O. BOX 237-023 Shanghai,  CN 200237
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-29
Decision Date2010-12-02

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