FDA 510(k) Application Details - K031202

Device Classification Name	Standard Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K031202
Device Name	Standard Polysomnograph With Electroencephalograph
Applicant	BRAEBON MEDICAL CORP. 120 WALGREEN DR (RR#3) SUITE #1 CARP, ONTARIO K0A 1L0 CA Other 510(k) Applications for this Company
Contact	RICHARD A BONATO 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	04/16/2003
Decision Date	05/01/2003
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	Y
Expedited Review