Giotto 类（型号 - 3000X-YY 和 4000X-YY）
K号: K200424 · 2020-06-18
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器械摘要
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.
常见问题
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.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Ims Giotto S.P.A.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：MUE）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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