E-EEGX, N-EEGX

Non-normalizing Quantitative Electroencephalograph Software

GE Healthcare Finland Oy

The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for E-eegx, N-eegx.

Pre-market Notification Details

Device IDK191322
510k NumberK191322
Device Name:E-EEGX, N-EEGX
ClassificationNon-normalizing Quantitative Electroencephalograph Software
Applicant GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki,  FI Fi-00510
ContactJoel Kent
CorrespondentJoel Kent
GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki,  FI Fi-00510
Product CodeOLT  
Subsequent Product CodeGWJ
Subsequent Product CodeMHX
Subsequent Product CodeMLD
Subsequent Product CodeOMC
Subsequent Product CodeORT
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
510k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-15
Decision Date2020-01-22

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