Part 868 Subpart C—Monitoring Devices
FDA submissions for Part 868 Subpart C—Monitoring Devices in the Ear, Nose, Throat (EN) review panel, including product codes, regulations, and recent device decisions.
Section range: § 868.2376
CFR Part: 868
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| QRS | Device For Sleep Apnea Testing Based On Mandibular Movement | 868.2376 | 2 | 3 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K250874 | Sunrise | Sunrise SA | Aug 29, 2025 |
| K222262 | Sunrise | Sunrise SA | Dec 22, 2022 |
| DEN210015 | Sunrise Sleep Disorder Diagnostic Aid | Sunrise | Jan 7, 2022 |
