FDA 510(k)

G-EYE 系統

K 號：K202469 · 2020-10-26

決定日期2020-10-26

產品代碼FDF

諮詢委員會GU

決定相當於

器材摘要

G-EYE System is the device name listed in this FDA 510(k) record. The listed applicant is Smart Medical Systems , Ltd.. It received FDA 510(k) clearance on 2020-10-26 under 510(k) number K202469. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the G-EYE System?

G-EYE System is a medical device that received FDA 510(k) clearance on 2020-10-26. The listed applicant is Smart Medical Systems , Ltd.. The 510(k) number is K202469.

When did G-EYE System receive FDA 510(k) clearance?

G-EYE System received FDA 510(k) clearance on 2020-10-26, under 510(k) number K202469.

Who is the listed applicant for G-EYE System?

The FDA 510(k) record lists Smart Medical Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G-EYE System?

The FDA product code for G-EYE System is FDF.

其他以 Smart Medical Systems , Ltd. 為申請人之記錄

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K220158G-EYE 系統 K192588G-EYE 系統

相關器械（代碼：FDF）

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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