cortiQ PRO— 510(k) K191432

Substantially Equivalent

G.Tec Medical Engineering GmbH

FDA 510(k) clearance K191432 for cortiQ PRO, Substantially Equivalent on 2020-01-24. Applicant: G.Tec Medical Engineering GmbH. Device class: 2.

Clearance details

Applicant: G.Tec Medical Engineering GmbH
Product code: Code OLU
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2019-05-29
Decision date: 2020-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schiedlberg, AT

Download summary PDF View on FDA.gov ↗

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