FDA 510(k)

HPR45i

K 號：K220725 · 2023-03-20

決定日期2023-03-20

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

HPR45i is the device name listed in this FDA 510(k) record. The listed applicant is F Care Systems USA, LLC. It received FDA 510(k) clearance on 2023-03-20 under 510(k) number K220725. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HPR45i?

HPR45i is a medical device that received FDA 510(k) clearance on 2023-03-20. The listed applicant is F Care Systems USA, LLC. The 510(k) number is K220725.

When did HPR45i receive FDA 510(k) clearance?

HPR45i received FDA 510(k) clearance on 2023-03-20, under 510(k) number K220725.

Who is the listed applicant for HPR45i?

The FDA 510(k) record lists F Care Systems USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HPR45i?

The FDA product code for HPR45i is GEI.

其他以 F Care Systems USA, 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。

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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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