FDA 510(k)

VBrain-OAR

K号: K212116 · 2021-10-12

决定日期2021-10-12

产品代码QKB

咨询委员会RA

决定实质等同

器械摘要

VBrain-OAR is the device name listed in this FDA 510(k) record. The listed applicant is Vysioneer, Inc.. It received FDA 510(k) clearance on 2021-10-12 under 510(k) number K212116. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VBrain-OAR?

VBrain-OAR is a medical device that received FDA 510(k) clearance on 2021-10-12. The listed applicant is Vysioneer, Inc.. The 510(k) number is K212116.

When did VBrain-OAR receive FDA 510(k) clearance?

VBrain-OAR received FDA 510(k) clearance on 2021-10-12, under 510(k) number K212116.

Who is the listed applicant for VBrain-OAR?

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

What is the FDA product code for VBrain-OAR?

The FDA product code for VBrain-OAR is QKB.

列明Vysioneer, Inc.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。

K213628VBrain K203235VBrain

官方来源

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