510(k) K252981 ยท LEL Device, Sleep Assessment
EmbraceMini
| Applicant | Empatica S.r.l., Milan, IT |
| Decision | Substantially Equivalent, Dec 22, 2025 |
| Received | Sep 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252981
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.