510(k) K253301 · GWF Stimulator, Electrical, Evoked Response
BraiN20® (BraiN20)
| Applicant | Time IS Brain, S.L., Badalona, ES |
| Decision | Substantially Equivalent, Jun 27, 2026 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253301
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.