510(k) K223573 ยท MNR Ventilatory Effort Recorder
Onera Sleep Test System (Onera STS)
| Applicant | Onera B.V., Eindhoven, NL |
| Decision | Substantially Equivalent, Aug 18, 2023 |
| Received | Nov 30, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223573
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.