Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)
Device Facts
| Record ID | K261604 |
|---|---|
| Device Name | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) |
| Applicant | Neuroelectrics Barcelona S.L.U. |
| Product Code | GWQ · Neurology |
| Decision Date | Jun 13, 2026 |
| Decision | SESE |
| Submission Type | Special |
| 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.
