g.Estim FES
K-Number: K200088 · 2020-10-29
ApplicantG.Tec Medical Engineering GmbH
Decision Date2020-10-29
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
g.Estim FES is a medical device manufactured by G.Tec Medical Engineering GmbH. It received FDA 510(k) clearance on 2020-10-29 under approval number K200088. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the g.Estim FES?
g.Estim FES is a medical device that received FDA 510(k) clearance on 2020-10-29. It is manufactured by G.Tec Medical Engineering GmbH. The 510(k) number is K200088.
When was g.Estim FES approved by the FDA?
g.Estim FES received FDA 510(k) clearance on 2020-10-29, under approval number K200088.
What company makes g.Estim FES?
g.Estim FES is manufactured by G.Tec Medical Engineering GmbH.
What is the FDA product code for g.Estim FES?
The FDA product code for g.Estim FES is IPF.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.