FDA 510(k)

VBrain

K-Number: K213628 · 2021-12-16

Decision Date2021-12-16

Product CodeQKB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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 2021-12-16 under 510(k) number K213628. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VBrain?

VBrain is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Vysioneer, Inc.. The 510(k) number is K213628.

When did VBrain receive FDA 510(k) clearance?

VBrain received FDA 510(k) clearance on 2021-12-16, under 510(k) number K213628.

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.

Other records listing Vysioneer, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.