510(k) K223504 ยท OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Ceribell Status Epilepticus Monitor
| Applicant | Ceribell, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, May 23, 2023 |
| Received | Nov 22, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223504
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.