Giotto Class (Models - 3000X-YY and 4000X-YY)
K-Number: K200424 · 2020-06-18
ApplicantIms Giotto S.P.A.
Decision Date2020-06-18
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Giotto Class (Models - 3000X-YY and 4000X-YY) is a medical device manufactured by Ims Giotto S.P.A.. It received FDA 510(k) clearance on 2020-06-18 under approval number K200424. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by Ims Giotto S.P.A.. The 510(k) number is K200424.
When was Giotto Class (Models - 3000X-YY and 4000X-YY) approved by the FDA?
Giotto Class (Models - 3000X-YY and 4000X-YY) received FDA 510(k) clearance on 2020-06-18, under approval number K200424.
What company makes Giotto Class (Models - 3000X-YY and 4000X-YY)?
Giotto Class (Models - 3000X-YY and 4000X-YY) is manufactured by Ims Giotto S.P.A..
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.
Related Clinical Trials
Other Devices by Ims Giotto S.P.A.
Related Devices (Code: MUE)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.