510(k) K253015 ยท OLU Normalizing Quantitative Electroencephalograph Software
Cognitive Function Neuroimaging (cfNI) Software (1.0.0)
| Applicant | VoxNeuro, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Jun 12, 2026 |
| Received | Sep 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253015
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.