Sana Device
FDA 510(k) clearance DEN250005 · decided 2026-01-16
Clearance details
- K-number
- DEN250005
- Device name
- Sana Device
- Applicant
- Sana Health
- Decision
- Unknown
- Date received
- 2025-03-03
- Decision date
- 2026-01-16
- Days to decision
- 319 days
- Clearance type
- Direct
- Product code
- QYN
- Device class
- 1
- Regulation number
- 890.5775
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Louisville, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.