FDA 510(k)

VBrain

K号: K203235 · 2021-03-19

决定日期2021-03-19

产品代码QKB

咨询委员会RA

决定实质等同

器械摘要

VBrain is the device name listed in this FDA 510(k) record. The listed applicant is Vysioneer, Inc.. It received FDA 510(k) clearance on 2021-03-19 under 510(k) number K203235. 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?

VBrain is a medical device that received FDA 510(k) clearance on 2021-03-19. The listed applicant is Vysioneer, Inc.. The 510(k) number is K203235.

When did VBrain receive FDA 510(k) clearance?

VBrain received FDA 510(k) clearance on 2021-03-19, under 510(k) number K203235.

Who is the listed applicant for VBrain?

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?

The FDA product code for VBrain 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 K212116VBrain-OAR

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。