510(k) K261712 ยท OLT Non-Normalizing Quantitative Electroencephalograph Software
Ceribell EEG Analysis Software
| Applicant | Ceribell, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 16, 2026 |
| Received | May 22, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261712
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.