FDA 510(k) Application Details - K010543

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K010543
Device Name	Electrode, Cutaneous
Applicant	KATECHO, INC. 2500 BELL AVE. P.O. BOX 21247 DES MOINES, IA 50321 US Other 510(k) Applications for this Company
Contact	WARREN R WALTERS 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	02/23/2001
Decision Date	05/23/2001
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