K253015
- 510(k) number
- K253015
- Device name
- Cognitive Function Neuroimaging (cfNI) Software (1.0.0)
- Applicant
- VoxNeuro, Inc. CA
- Product code
- OLU — Normalizing Quantitative Electroencephalograph Softw
- Decision date
- 2026-06-12
- Date received
- 2025-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253015.pdf
Official FDA record: K253015
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.