Clearance Summary
Sunrise Sleep Disorder Diagnostic Aid received FDA 510(k) clearance under submission number DEN210015, sponsored by Sunrise. The device was reviewed via the Direct premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2022-01-07.
- Submission: DEN210015
- Applicant / Sponsor: Sunrise
- Clearance pathway: Direct
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 868.2376
- Decision date: 2022-01-07
Classification & Regulation
This clearance is catalogued under FDA product code QRS and 21 CFR 868.2376, within the Ear, Nose, Throat review panel as a Class II device.