DEN250005
- 510(k) number
- DEN250005
- Device name
- Sana Device
- Applicant
- Sana Health CO · US
- Product code
- QYN — Prescription Audiovisual Stimulator (Avs) For Tempor
- Decision date
- 2026-01-16
- Date received
- 2025-03-03
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Physical Medicine
Official FDA record: DEN250005
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.