FDA 510(k) Application Details - K941823

Device Classification Name	Generator, Lesion, Radiofrequency   More FDA Info for this Device
510(K) Number	K941823
Device Name	Generator, Lesion, Radiofrequency
Applicant	ELEKTA INSTRUMENTS, INC. 8 EXECUTIVE PARK WEST ATLANTA, GA 30329 US Other 510(k) Applications for this Company
Contact	SVERKER GLANS Other 510(k) Applications for this Contact
Regulation Number	882.4400   More FDA Info for this Regulation Number
Classification Product Code	GXD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/13/1994
Decision Date	03/22/1996
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