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FDA 510(k)

Aurora-RT

K 號:K213526 · 2022-05-04

決定日期2022-05-04
產品代碼IYE
諮詢委員會RA
決定相當於

器材摘要

Aurora-RT is the device name listed in this FDA 510(k) record. The listed applicant is Magnettx Oncology Solutions , Ltd.. It received FDA 510(k) clearance on 2022-05-04 under 510(k) number K213526. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aurora-RT?

Aurora-RT is a medical device that received FDA 510(k) clearance on 2022-05-04. The listed applicant is Magnettx Oncology Solutions , Ltd.. The 510(k) number is K213526.

When did Aurora-RT receive FDA 510(k) clearance?

Aurora-RT received FDA 510(k) clearance on 2022-05-04, under 510(k) number K213526.

Who is the listed applicant for Aurora-RT?

The FDA 510(k) record lists Magnettx Oncology Solutions , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aurora-RT?

The FDA product code for Aurora-RT is IYE.

相關臨床試驗

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相關器械(代碼:IYE)

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。

官方來源

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