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FDA 510(k)

RadGil2

K 號:K201177 · 2020-08-17

決定日期2020-08-17
產品代碼MOT
決定相當於

器材摘要

RadGil2 is the device name listed in this FDA 510(k) record. The listed applicant is R3 X-Ray L.L.C. It received FDA 510(k) clearance on 2020-08-17 under 510(k) number K201177. The device is classified under product code MOT. FDA Decision: Substantially Equivalent.

常見問題

What is the RadGil2?

RadGil2 is a medical device that received FDA 510(k) clearance on 2020-08-17. The listed applicant is R3 X-Ray L.L.C. The 510(k) number is K201177.

When did RadGil2 receive FDA 510(k) clearance?

RadGil2 received FDA 510(k) clearance on 2020-08-17, under 510(k) number K201177.

Who is the listed applicant for RadGil2?

The FDA 510(k) record lists R3 X-Ray L.L.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RadGil2?

The FDA product code for RadGil2 is MOT.

相關臨床試驗

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相關器械(代碼:MOT)

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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