FDA 510(k)

SET-5002

K号: K240827 · 2024-05-24

申请人Shimadzu Corporation Medical Systems Division

决定日期2024-05-24

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

SET-5002 is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corporation Medical Systems Division. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K240827. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SET-5002?

SET-5002 is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Shimadzu Corporation Medical Systems Division. The 510(k) number is K240827.

When did SET-5002 receive FDA 510(k) clearance?

SET-5002 received FDA 510(k) clearance on 2024-05-24, under 510(k) number K240827.

Who is the listed applicant for SET-5002?

The FDA 510(k) record lists Shimadzu Corporation Medical Systems Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SET-5002?

The FDA product code for SET-5002 is KPS.

列明Shimadzu Corporation Medical Systems Division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。

K221922Trinias

相关器械（代码：KPS）

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

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