K252070
- 510(k) number
- K252070
- Device name
- Ceribell Infant Seizure Detection Software
- Applicant
- Ceribell, Inc. CA · US
- Product code
- OMB — Automatic Event Detection Software For Full-Montage
- Decision date
- 2025-11-21
- Date received
- 2025-07-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252070.pdf
Official FDA record: K252070
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.