AquaC UNO H
K 號：K250471 · 2025-11-14
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器材摘要
AquaC UNO H is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2025-11-14 under 510(k) number K250471. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AquaC UNO H?
AquaC UNO H is a medical device that received FDA 510(k) clearance on 2025-11-14. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K250471.
When did AquaC UNO H receive FDA 510(k) clearance?
AquaC UNO H received FDA 510(k) clearance on 2025-11-14, under 510(k) number K250471.
Who is the listed applicant for AquaC UNO H?
FDA 510(k) 記錄中將 Fresenius Medical Care Renal Therapies Group, LLC 列為申請人。這並不單獨確立設備製造商的身份。
What is the FDA product code for AquaC UNO H?
The FDA product code for AquaC UNO H is FIP.
相關臨床試驗
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其他以 Fresenius Medical Care Renal Therapies Group, LLC 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：FIP）
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。
K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLCK252181AquaAFresenius Medical Care North AmericaK250514UPT系列醫療RO水處理系統Specialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLCK223479AQUAbase nXB.Braun Medical, Inc.K231410RenaPure 結核菌內毒素濾過器Evoqua Water Technologies, LLC
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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