FDA 510(k)

EUROPA® 导航仪器

K号: K230369 · 2023-06-23

决定日期2023-06-23

产品代码OLO

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决定实质等同

器械摘要

EUROPA™ Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is MiRus, LLC. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K230369. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EUROPA™ Navigated Instruments?

EUROPA™ Navigated Instruments is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is MiRus, LLC. The 510(k) number is K230369.

When did EUROPA™ Navigated Instruments receive FDA 510(k) clearance?

EUROPA™ Navigated Instruments received FDA 510(k) clearance on 2023-06-23, under 510(k) number K230369.

Who is the listed applicant for EUROPA™ Navigated Instruments?

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

What is the FDA product code for EUROPA™ Navigated Instruments?

The FDA product code for EUROPA™ Navigated Instruments is OLO.

列明MiRus, LLC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。

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官方来源

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