FDA 510(k) Application Details - DEN130022

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130022
Device Name	NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR
Applicant	ENEURA THERAPEUTICS 2690 PHEASANT ROAD ORONO, MN 55331 US Other 510(k) Applications for this Company
Contact	LARRY GETLIN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2013
Decision Date	12/13/2013
Decision	DENG -
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review