K233618 is an FDA 510(k) clearance for the Oxevision Sleep Device. This device is classified as a Device, Sleep Assessment (Class II - Special Controls, product code LEL).
Submitted by Oxehealth Limited (Oxford, GB). The FDA issued a Cleared decision on April 3, 2024, 142 days after receiving the submission on November 13, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5050.
| 510(k) Number | K233618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2023 |
| Decision Date | April 03, 2024 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | LEL - Device, Sleep Assessment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5050 |