510(k) K250874
- Device
- Sunrise
- Applicant
- Sunrise SA
- 510(k) number
- K250874
- Product code
- QRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-29
- Date received
- 2025-03-24
- Regulation
- 868.2376
- Classification name
- Device For Sleep Apnea Testing Based On Mandibular Movement
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Grégoire Lejeune
- Address
- Chaussée De Marche, 598/02 Namur BE 5101 5101
FDA Registration Numbers#
- 3022505448