FDA 510(k)

CoreLink 导航仪器

K号: K214059 · 2022-01-19

决定日期2022-01-19

产品代码OLO

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决定实质等同

器械摘要

CoreLink Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Corelink, LLC. It received FDA 510(k) clearance on 2022-01-19 under 510(k) number K214059. 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 CoreLink Navigation Instruments?

CoreLink Navigation Instruments is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is Corelink, LLC. The 510(k) number is K214059.

When did CoreLink Navigation Instruments receive FDA 510(k) clearance?

CoreLink Navigation Instruments received FDA 510(k) clearance on 2022-01-19, under 510(k) number K214059.

Who is the listed applicant for CoreLink Navigation Instruments?

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

What is the FDA product code for CoreLink Navigation Instruments?

The FDA product code for CoreLink Navigation Instruments is OLO.

列明Corelink, 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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