FDA 510(k)

摩納哥RTP系統

K 號：K183037 · 2018-12-04

決定日期2018-12-04

產品代碼MUJ

諮詢委員會RA

決定相當於

器材摘要

Monaco RTP System is the device name listed in this FDA 510(k) record. The listed applicant is Elekta, Inc.. It received FDA 510(k) clearance on 2018-12-04 under 510(k) number K183037. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Monaco RTP System?

Monaco RTP System is a medical device that received FDA 510(k) clearance on 2018-12-04. The listed applicant is Elekta, Inc.. The 510(k) number is K183037.

When did Monaco RTP System receive FDA 510(k) clearance?

Monaco RTP System received FDA 510(k) clearance on 2018-12-04, under 510(k) number K183037.

Who is the listed applicant for Monaco RTP System?

The FDA 510(k) record lists Elekta, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monaco RTP System?

The FDA product code for Monaco RTP System is MUJ.

其他以 Elekta, Inc. 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。

K190178摩納哥RTP系統 K183034MOSAIQ 癌症資訊系統

相關器械（代碼：MUJ）

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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