GEODESIC EEG MOBILE 100 (GEM 100)

Full-montage Standard Electroencephalograph

ELECTRICAL GEODESICS, INC.

The following data is part of a premarket notification filed by Electrical Geodesics, Inc. with the FDA for Geodesic Eeg Mobile 100 (gem 100).

Pre-market Notification Details

Device IDK112353
510k NumberK112353
Device Name:GEODESIC EEG MOBILE 100 (GEM 100)
ClassificationFull-montage Standard Electroencephalograph
Applicant ELECTRICAL GEODESICS, INC. 29611 SIMMONS ROAD Eugene,  OR  97405
ContactLinda J Bovard
CorrespondentLinda J Bovard
ELECTRICAL GEODESICS, INC. 29611 SIMMONS ROAD Eugene,  OR  97405
Product CodeGWQ  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-16
Decision Date2012-02-17
Summary:summary

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