FDA 510(k) Application Details - K191301

Device Classification Name	Automatic Event Detection Software For Full-Montage Electroencephalograph   More FDA Info for this Device
510(K) Number	K191301
Device Name	Automatic Event Detection Software For Full-Montage Electroencephalograph
Applicant	Ceribell, Inc. 2483 Old Middlefield Way, Suite 120 Mountain View, CA 94043 US Other 510(k) Applications for this Company
Contact	Josef Parvizi 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	05/14/2019
Decision Date	09/11/2019
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