510(k) K210034 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
EnsoSleep
| Applicant | Ensodata, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Jun 16, 2021 |
| Received | Jan 6, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210034
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.