FDA 510(k)

기오토 클래스 (모델 - 3000X-YY 및 4000X-YY)

K-번호: K200424 · 2020-06-18

결정일2020-06-18

제품 코드MUE

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

Ims Giotto S.P.A.를 신청인으로 등재한 기타 기록

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