K210593 is an FDA 510(k) clearance for the Onera Sleep Test System (Onera STS). This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Onera B.V. (Eindhoven, NL). The FDA issued a Cleared decision on April 6, 2022, 401 days after receiving the submission on March 1, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K210593 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2021 |
| Decision Date | April 06, 2022 |
| Days to Decision | 401 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | MNR — Ventilatory Effort Recorder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |