CortiQ PRO

Normalizing Quantitative Electroencephalograph Software

G.tec Medical Engineering GmbH

The following data is part of a premarket notification filed by G.tec Medical Engineering Gmbh with the FDA for Cortiq Pro.

Pre-market Notification Details

Device IDK191432
510k NumberK191432
Device Name:CortiQ PRO
ClassificationNormalizing Quantitative Electroencephalograph Software
Applicant g.tec Medical Engineering GmbH Sierningerstrasse 14 Schiedlberg,  AT 4521
ContactChristoph Guger
CorrespondentChristoph Guger
g.tec Medical Engineering GmbH Sierningerstrasse 14 Schiedlberg,  AT 4521
Product CodeOLU  
Subsequent Product CodeGWL
Subsequent Product CodeOLT
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
510k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-05-29
Decision Date2020-01-24

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