510(k) K243515 ยท POS Physiological Signal Based Seizure Monitoring System
EpiWatch Monitoring System
| Applicant | Epiwatch, Inc., Baltimore MD, US |
| Decision | Substantially Equivalent, Mar 7, 2025 |
| Received | Nov 13, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243515
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.