510(k) K210593 ยท MNR Ventilatory Effort Recorder
Onera Sleep Test System (Onera STS)
| Applicant | Onera B.V., Eindhoven, NL |
| Decision | Substantially Equivalent, Apr 6, 2022 |
| Received | Mar 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210593
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.