BrainSee
FDA 510(k) clearance DEN220066 · decided 2024-01-11
Clearance details
- K-number
- DEN220066
- Device name
- BrainSee
- Applicant
- Darmiyan, Inc.
- Decision
- Unknown
- Date received
- 2022-09-29
- Decision date
- 2024-01-11
- Days to decision
- 469 days
- Clearance type
- Direct
- Product code
- QWT
- Device class
- 2
- Regulation number
- 882.1454
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Berkeley, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.