K241589

Substantially Equivalent

Ceribell Seizure Detection Software

Applicant: Ceribell, Inc.
Product code: OMB
Advisory panel: Neurology
Date received: 2024-06-03
Decision date: 2025-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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