FDA 510(k) Application Details - K051830

Device Classification Name	Electrode, Depth   More FDA Info for this Device
510(K) Number	K051830
Device Name	Electrode, Depth
Applicant	ALPHA OMEGA LTD. HA'AVODA ST., P.O. BOX 810 NAZARETH ILLIT 17105 IL Other 510(k) Applications for this Company
Contact	SHLOMO PUNDAK Other 510(k) Applications for this Contact
Regulation Number	882.1330   More FDA Info for this Regulation Number
Classification Product Code	GZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2005
Decision Date	09/16/2005
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