510(k) K182227 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Esprit Nova
| Applicant | Neurozone Msh Incorporated, Dundas, CA |
| Decision | Substantially Equivalent, Jan 17, 2019 |
| Received | Aug 16, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182227
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.