FDA 510(k)

ジオット・クラス（モデル：3000X-YYおよび4000X-YY）

K番号: K200424 · 2020-06-18

決定日2020-06-18

製品コードMUE

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてIms Giotto S.P.A.を記載するその他の記録

K203509スマート・ファインダー

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