510(k) K223163 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Sleepiz One+
| Applicant | Sleepiz AG, Zurich, CH |
| Decision | Substantially Equivalent, Aug 18, 2023 |
| Received | Oct 7, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223163
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.