510(k) DEN220066
- Device
- BrainSee
- Applicant
- Darmiyan, Inc.
- 510(k) number
- DEN220066
- Product code
- QWT
- Decision
- Unknown (DENG)
- Decision date
- 2024-01-11
- Date received
- 2022-09-29
- Regulation
- 882.1454
- Classification name
- Prognostic Assessment Software Of Mild Cognitive Impairment
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Kaveh Vejdani
- Address
- 1425 Berkeley Way Berkeley CA US 94702 94702
FDA Registration Numbers
- 3030624673
Source Documents
510(k) summary PDF not indicated by FDA