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FDA 510(k)

AquaA

K 號：K213507 · 2022-07-27

申請人Fresenius Medical Care Rental Therapies Group, LLC
決定日期2022-07-27
產品代碼FIP
諮詢委員會GU
決定相當於

器材摘要

AquaA is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Rental Therapies Group, LLC. It received FDA 510(k) clearance on 2022-07-27 under 510(k) number K213507. 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 AquaA?

AquaA is a medical device that received FDA 510(k) clearance on 2022-07-27. The listed applicant is Fresenius Medical Care Rental Therapies Group, LLC. The 510(k) number is K213507.

When did AquaA receive FDA 510(k) clearance?

AquaA received FDA 510(k) clearance on 2022-07-27, under 510(k) number K213507.

Who is the listed applicant for AquaA?

The FDA 510(k) record lists Fresenius Medical Care Rental Therapies Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AquaA?

The FDA product code for AquaA is FIP.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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

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