一絲
K 號：K232182 · 2024-01-26
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器材摘要
One-Fil is the device name listed in this FDA 510(k) record. The listed applicant is Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2024-01-26 under 510(k) number K232182. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the One-Fil?
One-Fil is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is Mediclus Co., Ltd.. The 510(k) number is K232182.
When did One-Fil receive FDA 510(k) clearance?
One-Fil received FDA 510(k) clearance on 2024-01-26, under 510(k) number K232182.
Who is the listed applicant for One-Fil?
FDA 510(k) 紀錄將 Mediclus Co., Ltd. 列為申請人。這本身並不確立醫療器材製造商。
What is the FDA product code for One-Fil?
The FDA product code for One-Fil is KIF.
其他以 Mediclus Co., Ltd. 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：KIF）
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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