FDA 510(k) Application Details - K232052

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K232052
Device Name	Electrode, Cutaneous
Applicant	Ceribell, Inc. 360 North Pastoria Avenue Sunnyvale, CA 94085 US Other 510(k) Applications for this Company
Contact	Raymond Woo Other 510(k) Applications for this Contact
Regulation Number	882.1320   More FDA Info for this Regulation Number
Classification Product Code	GXY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/10/2023
Decision Date	08/08/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review