一次濾流器
K 號：K251283 · 2025-06-06
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器材摘要
Once-Fil Flow 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 2025-06-06 under 510(k) number K251283. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Once-Fil Flow?
Once-Fil Flow is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Mediclus Co., Ltd.. The 510(k) number is K251283.
When did Once-Fil Flow receive FDA 510(k) clearance?
Once-Fil Flow received FDA 510(k) clearance on 2025-06-06, under 510(k) number K251283.
Who is the listed applicant for Once-Fil Flow?
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 Once-Fil Flow?
The FDA product code for Once-Fil Flow is EBF.
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：EBF）
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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