FDA 510(k)

Fluobeam LX

K 號：K190891 · 2019-07-31

決定日期2019-07-31

產品代碼QDG

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Fluobeam LX is the device name listed in this FDA 510(k) record. The listed applicant is Fluoptics. It received FDA 510(k) clearance on 2019-07-31 under 510(k) number K190891. The device is classified under product code QDG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fluobeam LX?

Fluobeam LX is a medical device that received FDA 510(k) clearance on 2019-07-31. The listed applicant is Fluoptics. The 510(k) number is K190891.

When did Fluobeam LX receive FDA 510(k) clearance?

Fluobeam LX received FDA 510(k) clearance on 2019-07-31, under 510(k) number K190891.

Who is the listed applicant for Fluobeam LX?

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

What is the FDA product code for Fluobeam LX?

The FDA product code for Fluobeam LX is QDG.

相關器械（代碼：QDG）

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。

K253303樹突影像系統Dendrite Imaging, Inc.K250455FLUOBEAM LX 影像系統 (FBLX)；FLUOBEAM LM 影像系統 (FBLM)Fluoptics Sas (A Getinge Group Company}K233564FLUOBEAM® LX 影像系統 (FB-LX)；FLUOBEAM® LX 紅外線影像系統 (FB-LXR)Fluoptics Sas (A Getinge Group Company)K230898FLUOBEAM® LX 紅Fluoptics Sas

官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：QDG）

官方來源