510(k) K181861 ยท POS Physiological Signal Based Seizure Monitoring System
Embrace
| Applicant | Empatica S.r.l., Milano, IT |
| Decision | Substantially Equivalent, Dec 20, 2018 |
| Received | Jul 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181861
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2023 | EMPATICA SRL Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest.
Models:
(1) Flamingo Pink EM2-FP-S;
(2) Open, Classified |
POS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.