CONDUCTIVE EEG ELECTROLYTE

Media, Electroconductive

COMPUMEDICS USA, LTD.

The following data is part of a premarket notification filed by Compumedics Usa, Ltd. with the FDA for Conductive Eeg Electrolyte.

Pre-market Notification Details

Device IDK033052
510k NumberK033052
Device Name:CONDUCTIVE EEG ELECTROLYTE
ClassificationMedia, Electroconductive
Applicant COMPUMEDICS USA, LTD. 7850 PASEO DEL NORTE El Paso,  TX  79912
ContactElvira Garcia
CorrespondentElvira Garcia
COMPUMEDICS USA, LTD. 7850 PASEO DEL NORTE El Paso,  TX  79912
Product CodeGYB  
CFR Regulation Number882.1275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-29
Decision Date2003-12-17
Summary:summary

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