510(k) K223539 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Dreem 3S
| Applicant | Beacon Biosignals, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Aug 18, 2023 |
| Received | Nov 23, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223539
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.