FDA 510(k)

美維斯肝臟套件

K 號：K232045 · 2023-10-27

決定日期2023-10-27

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

MeVis Liver Suite is the device name listed in this FDA 510(k) record. The listed applicant is MeVis Medical Solutions AG. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K232045. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MeVis Liver Suite?

MeVis Liver Suite is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is MeVis Medical Solutions AG. The 510(k) number is K232045.

When did MeVis Liver Suite receive FDA 510(k) clearance?

MeVis Liver Suite received FDA 510(k) clearance on 2023-10-27, under 510(k) number K232045.

Who is the listed applicant for MeVis Liver Suite?

The FDA 510(k) record lists MeVis Medical Solutions AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MeVis Liver Suite?

The FDA product code for MeVis Liver Suite is JAK.

其他以 MeVis Medical Solutions AG 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。

K260576美維斯 AVM 輪廓 K201501維奧利蒂

相關器械（代碼：JAK）

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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