FDA 510(k) Application Details - DEN140040

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN140040
Device Name	Nautilus BrainPulse 1000
Applicant	JAN MEDICAL, INC. 110 Pioneer Way, Suite L Mountain View, CA 94041 US Other 510(k) Applications for this Company
Contact	Paul Lovoi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2014
Decision Date	08/01/2016
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