Felix NeuroAI System— 510(k) K250096

Substantially Equivalent

Fasikl Incorporated

FDA 510(k) clearance K250096 for Felix NeuroAI System, Substantially Equivalent on 2025-07-01. Applicant: Fasikl Incorporated.

Clearance details

Applicant: Fasikl Incorporated
Product code: Code QBC
Advisory panel: Neurology
Date received: 2025-01-14
Decision date: 2025-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, MN, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.