FDA 510(k)

iCare ALTIUS CW

K 號：K234076 · 2024-08-22

決定日期2024-08-22

產品代碼NFJ

諮詢委員會RA

決定相當於

器材摘要

iCare ALTIUS CW is the device name listed in this FDA 510(k) record. The listed applicant is Centervue S.P.A.. It received FDA 510(k) clearance on 2024-08-22 under 510(k) number K234076. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iCare ALTIUS CW?

iCare ALTIUS CW is a medical device that received FDA 510(k) clearance on 2024-08-22. The listed applicant is Centervue S.P.A.. The 510(k) number is K234076.

When did iCare ALTIUS CW receive FDA 510(k) clearance?

iCare ALTIUS CW received FDA 510(k) clearance on 2024-08-22, under 510(k) number K234076.

Who is the listed applicant for iCare ALTIUS CW?

The FDA 510(k) record lists Centervue S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iCare ALTIUS CW?

The FDA product code for iCare ALTIUS CW is NFJ.

其他以 Centervue S.P.A. 為申請人之記錄

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相關器械（代碼：NFJ）

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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