K243220 is an FDA 510(k) clearance for the Onera STS 2 (ONERA STS 2). 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 July 3, 2025, 269 days after receiving the submission on October 7, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K243220 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2024 |
| Decision Date | July 03, 2025 |
| Days to Decision | 269 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 |