GEODESIC EEG SYSTEM 300

Non-normalizing Quantitative Electroencephalograph Software

ELECTRICAL GEODESICS, INCORPORATED

The following data is part of a premarket notification filed by Electrical Geodesics, Incorporated with the FDA for Geodesic Eeg System 300.

Pre-market Notification Details

Device IDK063797
510k NumberK063797
Device Name:GEODESIC EEG SYSTEM 300
ClassificationNon-normalizing Quantitative Electroencephalograph Software
Applicant ELECTRICAL GEODESICS, INCORPORATED 29611 SIMMONS ROAD Eugene,  OR  97405
ContactLinda J Bovard
CorrespondentLinda J Bovard
ELECTRICAL GEODESICS, INCORPORATED 29611 SIMMONS ROAD Eugene,  OR  97405
Product CodeOLT  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-22
Decision Date2007-01-25
Summary:summary

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