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FDA 510(k)

Felix NeuroAI System

K-Number: K250096 · 2025-07-01

ApplicantFasikl Incorporated
Decision Date2025-07-01
Product CodeQBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Felix NeuroAI System is a medical device manufactured by Fasikl Incorporated. It received FDA 510(k) clearance on 2025-07-01 under approval number K250096. The device is classified under product code QBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Felix NeuroAI System?

Felix NeuroAI System is a medical device that received FDA 510(k) clearance on 2025-07-01. It is manufactured by Fasikl Incorporated. The 510(k) number is K250096.

When was Felix NeuroAI System approved by the FDA?

Felix NeuroAI System received FDA 510(k) clearance on 2025-07-01, under approval number K250096.

What company makes Felix NeuroAI System?

Felix NeuroAI System is manufactured by Fasikl Incorporated.

What is the FDA product code for Felix NeuroAI System?

The FDA product code for Felix NeuroAI System is QBC.

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Official Source

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