K250874
- 510(k) number
- K250874
- Device name
- Sunrise
- Applicant
- Sunrise SA BE
- Product code
- QRS — Device For Sleep Apnea Testing Based On Mandibular M
- Decision date
- 2025-08-29
- Date received
- 2025-03-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250874.pdf
Official FDA record: K250874
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.