510(k) K192469 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Nox Sleep System
| Applicant | Nox Medical, Reykjavik, IS |
| Decision | Substantially Equivalent, Nov 13, 2019 |
| Received | Sep 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192469
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.