FDA 510(k) Application Details - K170363

Device Classification Name	Reduced- Montage Standard Electroencephalograph   More FDA Info for this Device
510(K) Number	K170363
Device Name	Reduced- Montage Standard 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	OMC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/06/2017
Decision Date	05/08/2017
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