K253301
- 510(k) number
- K253301
- Device name
- BraiN20® (BraiN20)
- Applicant
- Time IS Brain, S.L. ES
- Product code
- GWF — Stimulator, Electrical, Evoked Response
- Decision date
- 2026-06-27
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253301.pdf
Official FDA record: K253301
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.