FDA 510(k) Application Details - DEN140032

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN140032
Device Name	Cereve Sleep System
Applicant	CEREVE, INC. 333 Allegheny Ave., 2nd Floor North Oakmont, PA 15139 US Other 510(k) Applications for this Company
Contact	Eric Nofzinger Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/20/2014
Decision Date	05/13/2016
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