510(k) K260363 ยท GXY Electrode, Cutaneous
Ceribell Brain Monitor Headband
| Applicant | Ceribell, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Apr 3, 2026 |
| Received | Feb 4, 2026 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K260363
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.