K261604
- 510(k) number
- K261604
- Device name
- Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)
- Applicant
- Neuroelectrics Barcelona S.L.U. ES
- Product code
- GWQ — Full-Montage Standard Electroencephalograph
- Decision date
- 2026-06-13
- Date received
- 2026-05-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K261604.pdf
Official FDA record: K261604
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.