E-Fit Infinity 系統（EF-2090 控制器及 EF-100 單位）
K 號：K202148 · 2021-08-25
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器材摘要
E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) is the device name listed in this FDA 510(k) record. The listed applicant is Fit-Pro , Ltd.. It received FDA 510(k) clearance on 2021-08-25 under 510(k) number K202148. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)?
E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) is a medical device that received FDA 510(k) clearance on 2021-08-25. The listed applicant is Fit-Pro , Ltd.. The 510(k) number is K202148.
When did E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) receive FDA 510(k) clearance?
E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) received FDA 510(k) clearance on 2021-08-25, under 510(k) number K202148.
Who is the listed applicant for E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)?
The FDA 510(k) record lists Fit-Pro , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)?
The FDA product code for E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) is NGX.
相關臨床試驗
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相關器械（代碼：NGX）
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。
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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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