510(k) K150369 ยท PLC Sleep Appliances With Patient Monitoring
SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with
| Applicant | Somnomed, Inc., Frisco TX, US |
| Decision | Substantially Equivalent, Jun 18, 2015 |
| Received | Feb 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150369
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.