FDA 510(k)

Remi机器人导航系统

K号: K223350 · 2023-03-13

决定日期2023-03-13

产品代码OLO

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决定实质等同

器械摘要

Remi Robotic Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Fusion Robotics, LLC. It received FDA 510(k) clearance on 2023-03-13 under 510(k) number K223350. 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 Remi Robotic Navigation System?

Remi Robotic Navigation System is a medical device that received FDA 510(k) clearance on 2023-03-13. The listed applicant is Fusion Robotics, LLC. The 510(k) number is K223350.

When did Remi Robotic Navigation System receive FDA 510(k) clearance?

Remi Robotic Navigation System received FDA 510(k) clearance on 2023-03-13, under 510(k) number K223350.

Who is the listed applicant for Remi Robotic Navigation System?

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

What is the FDA product code for Remi Robotic Navigation System?

The FDA product code for Remi Robotic Navigation System is OLO.

列明Fusion Robotics, 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。

K223070Remi机器人导航系统

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