FDA 510(k) Application Details - K042309

Device Classification Name	Reduced- Montage Standard Electroencephalograph   More FDA Info for this Device
510(K) Number	K042309
Device Name	Reduced- Montage Standard Electroencephalograph
Applicant	OXFORD BIOSIGNALS LIMITED 611 RIGGIN ROAD TROY, IL 62294 US Other 510(k) Applications for this Company
Contact	SIMON J GRIFFIN Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OMC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2004
Decision Date	09/08/2004
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