NEUROLOGY ACCESSORIES - MARK-EASY 10-20

Electrode, Cutaneous

OPTIMIT USA, INC.

The following data is part of a premarket notification filed by Optimit Usa, Inc. with the FDA for Neurology Accessories - Mark-easy 10-20.

Pre-market Notification Details

Device IDK942461
510k NumberK942461
Device Name:NEUROLOGY ACCESSORIES - MARK-EASY 10-20
ClassificationElectrode, Cutaneous
Applicant OPTIMIT USA, INC. 8522 EAST HELEN PLACE Tucson,  AZ  85715
ContactMarni C Patterson
CorrespondentMarni C Patterson
OPTIMIT USA, INC. 8522 EAST HELEN PLACE Tucson,  AZ  85715
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-24
Decision Date1994-10-19

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