FDA 510(k) Application Details - K982053

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K982053
Device Name	Electrode, Cutaneous
Applicant	CLASS A ENT. 7607 LUCERNE VISTA YUCCA VALLEY, CA 92284 US Other 510(k) Applications for this Company
Contact	JANICE A AUDI Other 510(k) Applications for this Contact
Regulation Number	882.1320   More FDA Info for this Regulation Number
Classification Product Code	GXY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/1998
Decision Date	04/20/1999
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