g.Estim FES
K 號：K200088 · 2020-10-29
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器材摘要
g.Estim FES is the device name listed in this FDA 510(k) record. The listed applicant is G.Tec Medical Engineering GmbH. It received FDA 510(k) clearance on 2020-10-29 under 510(k) number K200088. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the g.Estim FES?
g.Estim FES is a medical device that received FDA 510(k) clearance on 2020-10-29. The listed applicant is G.Tec Medical Engineering GmbH. The 510(k) number is K200088.
When did g.Estim FES receive FDA 510(k) clearance?
g.Estim FES received FDA 510(k) clearance on 2020-10-29, under 510(k) number K200088.
Who is the listed applicant for g.Estim FES?
The FDA 510(k) record lists G.Tec Medical Engineering GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for g.Estim FES?
The FDA product code for g.Estim FES is IPF.
相關臨床試驗
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其他以 G.Tec Medical Engineering GmbH 為申請人之記錄
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
相關器械（代碼：IPF）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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