FDA 510(k)

Velacur

K号: K232459 · 2023-09-12

决定日期2023-09-12

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

Velacur is the device name listed in this FDA 510(k) record. The listed applicant is Sonic Incytes. It received FDA 510(k) clearance on 2023-09-12 under 510(k) number K232459. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Velacur?

Velacur is a medical device that received FDA 510(k) clearance on 2023-09-12. The listed applicant is Sonic Incytes. The 510(k) number is K232459.

When did Velacur receive FDA 510(k) clearance?

Velacur received FDA 510(k) clearance on 2023-09-12, under 510(k) number K232459.

Who is the listed applicant for Velacur?

The FDA 510(k) record lists Sonic Incytes as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Velacur?

The FDA product code for Velacur is IYO.

列明Sonic Incytes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。

K233977Velacur K223287Velacur K201597Liver Incytes, 型号 1005

官方来源

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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。