510(k) K253388 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Sleepiz One+ (Model 2.5)
| Applicant | Sleepiz AG, Zurich, CH |
| Decision | Substantially Equivalent, Jan 28, 2026 |
| Received | Sep 30, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253388
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.