510(k) K163617 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
REMbrandt
| Applicant | Embla Systems, Kanata, CA |
| Decision | Substantially Equivalent, Apr 11, 2017 |
| Received | Dec 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163617
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.