510(k) K153353 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
SANDMAN ELITE
| Applicant | Embla Systems, Kanata, CA |
| Decision | Substantially Equivalent, Jun 23, 2016 |
| Received | Nov 20, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153353
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.