FDA 510(k) Application Details - K071449

Device Classification Name	Amplitude-Integrated Electroencephalograph   More FDA Info for this Device
510(K) Number	K071449
Device Name	Amplitude-Integrated Electroencephalograph
Applicant	BRAINZ INSTRUMENTS LTD. 25 CARBINE ROAD MT. WELLINGTON PO BOX 51-078, PARURANGA AUCKLAND NZ Other 510(k) Applications for this Company
Contact	CHRIS MANDER Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2007
Decision Date	09/14/2007
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