FDA 510(k)

AquaA

K 號：K252181 · 2025-09-09

決定日期2025-09-09

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 North America. It received FDA 510(k) clearance on 2025-09-09 under 510(k) number K252181. 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 2025-09-09. The listed applicant is Fresenius Medical Care North America. The 510(k) number is K252181.

When did AquaA receive FDA 510(k) clearance?

AquaA received FDA 510(k) clearance on 2025-09-09, under 510(k) number K252181.

Who is the listed applicant for AquaA?

The FDA 510(k) record lists Fresenius Medical Care North America 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.

其他以 Fresenius Medical Care North America 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。

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官方來源

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