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FDA 510(k)

Rayvolve PTX-PE

K号: K243808 · 2025-03-21

申请人AZmed
决定日期2025-03-21
产品代码QFM
咨询委员会RA
决定实质等同

器械摘要

Rayvolve PTX-PE is the device name listed in this FDA 510(k) record. The listed applicant is AZmed. It received FDA 510(k) clearance on 2025-03-21 under 510(k) number K243808. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Rayvolve PTX-PE?

Rayvolve PTX-PE is a medical device that received FDA 510(k) clearance on 2025-03-21. The listed applicant is AZmed. The 510(k) number is K243808.

When did Rayvolve PTX-PE receive FDA 510(k) clearance?

Rayvolve PTX-PE received FDA 510(k) clearance on 2025-03-21, under 510(k) number K243808.

Who is the listed applicant for Rayvolve PTX-PE?

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 PTX-PE?

The FDA product code for Rayvolve PTX-PE is QFM.

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。

相关器械(代码:QFM)

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。

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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