FDA 510(k) Application Details - K965079

Device Classification Name	Device, Sleep Assessment   More FDA Info for this Device
510(K) Number	K965079
Device Name	Device, Sleep Assessment
Applicant	NEURIM PHARMACEUTICALS, LTD. 12300 TWINBROOK PARKWAY, SUIT5 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	T. WHIT ATHEY Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LEL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/1996
Decision Date	07/10/1997
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