DEN220066
- 510(k) number
- DEN220066
- Device name
- BrainSee
- Applicant
- Darmiyan, Inc. CA · US
- Product code
- QWT — Prognostic Assessment Software Of Mild Cognitive Imp
- Decision date
- 2024-01-11
- Date received
- 2022-09-29
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Neurology
Official FDA record: DEN220066
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.