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FDA 510(k)

V5med Lung AI

K-Number: K242919 · 2025-03-27

ApplicantV5med, Inc.
Decision Date2025-03-27
Product CodeOEB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

V5med Lung AI is a medical device manufactured by V5med, Inc.. It received FDA 510(k) clearance on 2025-03-27 under approval number K242919. The device is classified under product code OEB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V5med Lung AI?

V5med Lung AI is a medical device that received FDA 510(k) clearance on 2025-03-27. It is manufactured by V5med, Inc.. The 510(k) number is K242919.

When was V5med Lung AI approved by the FDA?

V5med Lung AI received FDA 510(k) clearance on 2025-03-27, under approval number K242919.

What company makes V5med Lung AI?

V5med Lung AI is manufactured by V5med, Inc..

What is the FDA product code for V5med Lung AI?

The FDA product code for V5med Lung AI is OEB.

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Official Source

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