FDA 510(k)

SMART Bun-Yo-Matic CT

K号: K240642 · 2024-06-20

决定日期2024-06-20

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

SMART Bun-Yo-Matic CT is the device name listed in this FDA 510(k) record. The listed applicant is Disior, Ltd.. It received FDA 510(k) clearance on 2024-06-20 under 510(k) number K240642. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SMART Bun-Yo-Matic CT?

SMART Bun-Yo-Matic CT is a medical device that received FDA 510(k) clearance on 2024-06-20. The listed applicant is Disior, Ltd.. The 510(k) number is K240642.

When did SMART Bun-Yo-Matic CT receive FDA 510(k) clearance?

SMART Bun-Yo-Matic CT received FDA 510(k) clearance on 2024-06-20, under 510(k) number K240642.

Who is the listed applicant for SMART Bun-Yo-Matic CT?

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

What is the FDA product code for SMART Bun-Yo-Matic CT?

The FDA product code for SMART Bun-Yo-Matic CT is QIH.

列明Disior, Ltd.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。

K253764ENOS 软件引导的外固定系统 K250023SMART PCFD K240736SMART Bun-Yo-Matic X-Ray K223757Bonelogic K203290Bonelogic

官方来源

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