Felix NeuroAI System— 510(k) K250096
Substantially EquivalentFasikl Incorporated
FDA 510(k) clearance K250096 for Felix NeuroAI System, Substantially Equivalent on 2025-07-01. Applicant: Fasikl Incorporated. Device class: 2.
Clearance details
- Applicant
- Fasikl Incorporated
- Product code
- Code QBC
- Device class
- Class 2
- Regulation
- 21 CFR 882.5897
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomington, MN, US
Recent devices under product code QBC
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