FDA 510(k)

Giotto 等級（型號 - 3000X-YY 和 4000X-YY）

K 號：K200424 · 2020-06-18

決定日期2020-06-18

產品代碼MUE

諮詢委員會RA

決定相當於

器材摘要

Giotto Class (Models - 3000X-YY and 4000X-YY) is the device name listed in this FDA 510(k) record. The listed applicant is Ims Giotto S.P.A.. It received FDA 510(k) clearance on 2020-06-18 under 510(k) number K200424. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Giotto Class (Models - 3000X-YY and 4000X-YY)?

Giotto Class (Models - 3000X-YY and 4000X-YY) is a medical device that received FDA 510(k) clearance on 2020-06-18. The listed applicant is Ims Giotto S.P.A.. The 510(k) number is K200424.

When did Giotto Class (Models - 3000X-YY and 4000X-YY) receive FDA 510(k) clearance?

Giotto Class (Models - 3000X-YY and 4000X-YY) received FDA 510(k) clearance on 2020-06-18, under 510(k) number K200424.

Who is the listed applicant for Giotto Class (Models - 3000X-YY and 4000X-YY)?

The FDA 510(k) record lists Ims Giotto S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Giotto Class (Models - 3000X-YY and 4000X-YY)?

The FDA product code for Giotto Class (Models - 3000X-YY and 4000X-YY) is MUE.

其他以 Ims Giotto S.P.A. 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。

K203509SMART 搜尋器

相關器械（代碼：MUE）

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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