510(k) K190353 ยท PLC Sleep Appliances With Patient Monitoring
Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac
| Applicant | Residential Home Sleep Services, Battle Creek MI, US |
| Decision | Substantially Equivalent, Apr 10, 2020 |
| Received | Feb 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190353
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.