FDA 510(k) Application Details - K182311

Device Classification Name	More FDA Info for this Device
510(K) Number	K182311
Device Name	Cervella
Applicant	Innovative Neurological Devices LLC 13295 Illinois St, Suite 312 Carmel, IN 46032 US Other 510(k) Applications for this Company
Contact	Bart Waclawik Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2018
Decision Date	03/07/2019
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