Onera B.V.
FDA 510(k) & PMA Approved Devices — 4 products
Total Devices4
Categories2
Latest FDA decision2026-03-08
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253668 | Onera SleepMap (SLEEPMAP) | OLZ | 2026-03-08 | View |
| 510(k) | K243220 | Onera STS 2 (ONERA STS 2) | MNR | 2025-07-03 | View |
| 510(k) | K223573 | Onera Sleep Test System (Onera STS) | MNR | 2023-08-18 | View |
| 510(k) | K210593 | Onera Sleep Test System (Onera STS) | MNR | 2022-04-06 | View |
No matching devices.