510(k) K254304 ยท PLC Sleep Appliances With Patient Monitoring
iNOS intraoral biosensor
| Applicant | Achaemenid, LLC, Boston MA, US |
| Decision | Substantially Equivalent, Aug 25, 2026 |
| Received | Dec 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254304
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.