SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY

Electrode, Cutaneous

THE ELECTRODE STORE, INC.

The following data is part of a premarket notification filed by The Electrode Store, Inc. with the FDA for Surface Electrode For Electroencephalography.

Pre-market Notification Details

Device IDK022197
510k NumberK022197
Device Name:SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY
ClassificationElectrode, Cutaneous
Applicant THE ELECTRODE STORE, INC. 936-11TH AVENUE EAST Seattle,  WA  98102
ContactCarl Youngmann
CorrespondentCarl Youngmann
THE ELECTRODE STORE, INC. 936-11TH AVENUE EAST Seattle,  WA  98102
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-05
Decision Date2002-08-13

NIH GUDID Devices

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