510(k) K233438 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
SleepStageML
| Applicant | Beacon Biosignals, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Mar 8, 2024 |
| Received | Oct 13, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233438
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.