510(k) K161624 ยท PLC Sleep Appliances With Patient Monitoring
MicrO2 OSA Device with Micro-Recorder
| Applicant | Microdental, Inc., Dublin CA, US |
| Decision | Substantially Equivalent, Nov 7, 2016 |
| Received | Jun 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161624
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.