510(k) K252765 ยท PLC Sleep Appliances With Patient Monitoring
ProSomnus RPMO2 OSA Device (RPMO2 OSA)
| Applicant | Prosomnus Sleep Technologies, Pleasanton CA, US |
| Decision | Substantially Equivalent, Apr 6, 2026 |
| Received | Aug 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252765
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.