FDA 510(k) Application Details - K241589

Device Classification Name	Automatic Event Detection Software For Full-Montage Electroencephalograph   More FDA Info for this Device
510(K) Number	K241589
Device Name	Automatic Event Detection Software For Full-Montage Electroencephalograph
Applicant	Ceribell, Inc. 360 N Pastoria Ave Sunnyvale, CA 94085 US Other 510(k) Applications for this Company
Contact	Raymond Woo Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OMB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2024
Decision Date	04/09/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review