Helianthus
K号: K202822 · 2021-12-15
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器械摘要
Helianthus is the device name listed in this FDA 510(k) record. The listed applicant is Metaltronica Spa. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K202822. 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 Helianthus?
Helianthus is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Metaltronica Spa. The 510(k) number is K202822.
When did Helianthus receive FDA 510(k) clearance?
Helianthus received FDA 510(k) clearance on 2021-12-15, under 510(k) number K202822.
Who is the listed applicant for Helianthus?
The FDA 510(k) record lists Metaltronica Spa as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Helianthus?
The FDA product code for Helianthus is MUE.
相关临床试验
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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
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