FDA 510(k) Application Details - K981969

Device Classification Name	Device, Sleep Assessment   More FDA Info for this Device
510(K) Number	K981969
Device Name	Device, Sleep Assessment
Applicant	BRAEBON MEDICAL CORP. 63 ACKLAM TERRACE KANATA K2K 2H7 CA Other 510(k) Applications for this Company
Contact	RICHARD A BONATO 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	06/04/1998
Decision Date	08/20/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review