K241589
- 510(k) number
- K241589
- Device name
- Ceribell Seizure Detection Software
- Applicant
- Ceribell, Inc. CA · US
- Product code
- OMB — Automatic Event Detection Software For Full-Montage
- Decision date
- 2025-04-09
- Date received
- 2024-06-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K241589.pdf
Official FDA record: K241589
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.