FDA 510(k) Application Details - K981820

Device Classification Name	Electrode, Depth   More FDA Info for this Device
510(K) Number	K981820
Device Name	Electrode, Depth
Applicant	RADIONICS, INC. 22 TERRY AVE. BURLINGTON, MA 01803-2516 US Other 510(k) Applications for this Company
Contact	JEFFREY R MANNION 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	05/22/1998
Decision Date	11/20/1998
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