510(k) K254033 ยท GXY Electrode, Cutaneous
Ceribell Instant EEG Headset
| Applicant | Ceribell, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 9, 2026 |
| Received | Dec 16, 2025 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K254033
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.