Cognitive Function Neuroimaging (cfNI) Software (1.0.0)
Device Facts
| Record ID | K253015 |
|---|---|
| Device Name | Cognitive Function Neuroimaging (cfNI) Software (1.0.0) |
| Applicant | VoxNeuro, Inc. |
| Product Code | OLU · Neurology |
| Decision Date | Jun 12, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
