AmeriWater MediQA 反渗透系統 (MSP3HF)
K 號：K223656 · 2023-02-13
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器材摘要
AmeriWater MediQA Reverse Osmosis System (MSP3HF) is the device name listed in this FDA 510(k) record. The listed applicant is AmeriWater, LLC. It received FDA 510(k) clearance on 2023-02-13 under 510(k) number K223656. 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 AmeriWater MediQA Reverse Osmosis System (MSP3HF)?
AmeriWater MediQA Reverse Osmosis System (MSP3HF) is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is AmeriWater, LLC. The 510(k) number is K223656.
When did AmeriWater MediQA Reverse Osmosis System (MSP3HF) receive FDA 510(k) clearance?
AmeriWater MediQA Reverse Osmosis System (MSP3HF) received FDA 510(k) clearance on 2023-02-13, under 510(k) number K223656.
Who is the listed applicant for AmeriWater MediQA Reverse Osmosis System (MSP3HF)?
The FDA 510(k) record lists AmeriWater, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AmeriWater MediQA Reverse Osmosis System (MSP3HF)?
The FDA product code for AmeriWater MediQA Reverse Osmosis System (MSP3HF) is FIP.
相關臨床試驗
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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。
K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLCK251851DIASAFEplusUS (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.
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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