510(k) K230457 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
| Applicant | Empatica S.r.l., Milan, IT |
| Decision | Substantially Equivalent, Oct 30, 2023 |
| Received | Feb 21, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230457
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.