FDA 510(k)

AQUAbase nX

K 號：K223479 · 2023-08-16

決定日期2023-08-16

產品代碼FIP

諮詢委員會GU

決定相當於

器材摘要

AQUAbase nX is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2023-08-16 under 510(k) number K223479. 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 AQUAbase nX?

AQUAbase nX is a medical device that received FDA 510(k) clearance on 2023-08-16. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K223479.

When did AQUAbase nX receive FDA 510(k) clearance?

AQUAbase nX received FDA 510(k) clearance on 2023-08-16, under 510(k) number K223479.

Who is the listed applicant for AQUAbase nX?

FDA 510(k) 記錄將 B.Braun Medical, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for AQUAbase nX?

The FDA product code for AQUAbase nX is FIP.

其他以 B.Braun Medical, Inc. 為申請人之記錄

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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, LLC K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC K252181AquaAFresenius Medical Care North America K250514UPT系列醫療RO水處理系統Specialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLC K231410RenaPure 結核菌內毒素濾過器Evoqua Water Technologies, LLC

官方來源

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