g.Estim FES— 510(k) K200088

Substantially Equivalent

G.Tec Medical Engineering GmbH

FDA 510(k) clearance K200088 for g.Estim FES, Substantially Equivalent on 2020-10-29. Applicant: G.Tec Medical Engineering GmbH. Device class: 2.

Clearance details

Applicant: G.Tec Medical Engineering GmbH
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2020-01-15
Decision date: 2020-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schiedlberg, AT

Download summary PDF View on FDA.gov ↗

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