510(k) DEN210015
- Device
- Sunrise Sleep Disorder Diagnostic Aid
- Applicant
- Sunrise
- 510(k) number
- DEN210015
- Product code
- QRS
- Decision
- Unknown (DENG)
- Decision date
- 2022-01-07
- Date received
- 2021-04-02
- 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
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Francois Naye
- Address
- Chaussée De Marche 569/13 Namur BE 5101 5101
FDA Registration Numbers#
- 3022505448
Source Documents#
510(k) summary PDF not indicated by FDA