DeviceClearance

Ceribell Infant Seizure Detection Software— 510(k) K252070

Substantially Equivalent

Ceribell, Inc.

FDA 510(k) clearance K252070 for Ceribell Infant Seizure Detection Software, Substantially Equivalent on 2025-11-21. Applicant: Ceribell, Inc..

Clearance details

Applicant
Ceribell, Inc.
Product code
Code OMB
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sunnyvale, CA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.