FDA 510(k) Application Details - K991900

Device Classification Name	Standard Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K991900
Device Name	Standard Polysomnograph With Electroencephalograph
Applicant	EXCEL TECH. LTD. 2892 PORTLAND DR. OAKVILLE,ONTARIO L6H 5W8 CA Other 510(k) Applications for this Company
Contact	MARK T ZAJAC Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/1999
Decision Date	07/12/1999
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