FDA 510(k) Application Details - K022037

Device Classification Name	Standard Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K022037
Device Name	Standard Polysomnograph With Electroencephalograph
Applicant	EXCEL TECH. LTD. 2568 BRISTOL CIRCLE OAKVILLE, ONTARIO L6H 5S1 CA Other 510(k) Applications for this Company
Contact	SONJA MARKEZ 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	06/24/2002
Decision Date	09/10/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review