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FDA 510(k)

运动校正系统

K号: K193324 · 2020-02-04

决定日期2020-02-04
产品代码LNH
咨询委员会RA
决定实质等同

器械摘要

Motion Correction System is the device name listed in this FDA 510(k) record. The listed applicant is Kineticor, Inc.. It received FDA 510(k) clearance on 2020-02-04 under 510(k) number K193324. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Motion Correction System?

Motion Correction System is a medical device that received FDA 510(k) clearance on 2020-02-04. The listed applicant is Kineticor, Inc.. The 510(k) number is K193324.

When did Motion Correction System receive FDA 510(k) clearance?

Motion Correction System received FDA 510(k) clearance on 2020-02-04, under 510(k) number K193324.

Who is the listed applicant for Motion Correction System?

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

What is the FDA product code for Motion Correction System?

The FDA product code for Motion Correction System is LNH.

相关临床试验

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相关器械(代码:LNH)

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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