510(k) K252070 ยท OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Ceribell Infant Seizure Detection Software
| Applicant | Ceribell, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Nov 21, 2025 |
| Received | Jul 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252070
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.