FDA 510(k)

VUNO Med-DeepBrain

K-Number: K231398 · 2023-10-04

Decision Date2023-10-04

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

VUNO Med-DeepBrain is the device name listed in this FDA 510(k) record. The listed applicant is Vuno, Inc.. It received FDA 510(k) clearance on 2023-10-04 under 510(k) number K231398. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VUNO Med-DeepBrain?

VUNO Med-DeepBrain is a medical device that received FDA 510(k) clearance on 2023-10-04. The listed applicant is Vuno, Inc.. The 510(k) number is K231398.

When did VUNO Med-DeepBrain receive FDA 510(k) clearance?

VUNO Med-DeepBrain received FDA 510(k) clearance on 2023-10-04, under 510(k) number K231398.

Who is the listed applicant for VUNO Med-DeepBrain?

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

What is the FDA product code for VUNO Med-DeepBrain?

The FDA product code for VUNO Med-DeepBrain is QIH.

Other records listing Vuno, 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.

K241439VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage

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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.