g.Nautilus PRO— 510(k) K171669

Substantially Equivalent

G.Tec Medical Engineering GmbH

FDA 510(k) clearance K171669 for g.Nautilus PRO, Substantially Equivalent on 2017-07-05. Applicant: G.Tec Medical Engineering GmbH. Device class: 2.

Clearance details

Applicant: G.Tec Medical Engineering GmbH
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 2017-06-05
Decision date: 2017-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schiedlberg, AT

Download summary PDF View on FDA.gov ↗

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