Cleared Traditional

cortiQ PRO

K191432 · G.Tec Medical Engineering GmbH · Neurology
Jan 2020
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K191432 is an FDA 510(k) clearance for the cortiQ PRO, a Normalizing Quantitative Electroencephalograph Software (Class II — Special Controls, product code OLU), submitted by G.Tec Medical Engineering GmbH (Schiedlberg, AT). The FDA issued a Cleared decision on January 24, 2020, 240 days after receiving the submission on May 29, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K191432 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2019
Decision Date January 24, 2020
Days to Decision 240 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OLU — Normalizing Quantitative Electroencephalograph Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1400
Definition Post-hoc Statistical Analysis Of Electroencephalograph Signals With Comparison To A Normative Database For Interpretation By A Qualified User.