510(k) K250058 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
NEAT 001
| Applicant | Brain Electrophysiology Laboratory Company, LLC, Eugene OR, US |
| Decision | Substantially Equivalent, Apr 10, 2025 |
| Received | Jan 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250058
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.