K223573 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 August 18, 2023, 261 days after receiving the submission on November 30, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K223573 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2022 |
| Decision Date | August 18, 2023 |
| Days to Decision | 261 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 |