K252923
- 510(k) number
- K252923
- Device name
- IASIS i2 Relaxation Neurofeedback System
- Applicant
- Iasis Technologies CA · US
- Decision date
- 2026-03-13
- Date received
- 2025-09-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
510(k) Summary (official FDA PDF): K252923.pdf
Official FDA record: K252923
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.