FDA 510(k)

Rayvolve

K号: K260378 · 2026-05-12

申请人AZmed

决定日期2026-05-12

产品代码QBS

咨询委员会RA

决定实质等同

器械摘要

Rayvolve is the device name listed in this FDA 510(k) record. The listed applicant is AZmed. It received FDA 510(k) clearance on 2026-05-12 under 510(k) number K260378. The device is classified under product code QBS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Rayvolve?

Rayvolve is a medical device that received FDA 510(k) clearance on 2026-05-12. The listed applicant is AZmed. The 510(k) number is K260378.

When did Rayvolve receive FDA 510(k) clearance?

Rayvolve received FDA 510(k) clearance on 2026-05-12, under 510(k) number K260378.

Who is the listed applicant for Rayvolve?

FDA 510(k)记录显示AZmed为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Rayvolve?

The FDA product code for Rayvolve is QBS.

列明AZmed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。

K261378瑞沃莱 AZchest K243831Rayvolve LN K243808Rayvolve PTX-PE

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。