510(k) K181571 ยท PLC Sleep Appliances With Patient Monitoring
OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor
| Applicant | Mark Abramson, D.D.S., Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Apr 19, 2019 |
| Received | Jun 14, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181571
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.