FDA 510(k) Application Details - K111737

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K111737
Device Name	Electrode, Cutaneous
Applicant	SANIBEL SUPPLY DREJERVAENGET 8 ASSENS DK-5610 DK Other 510(k) Applications for this Company
Contact	ERIK NIELSEN 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	06/21/2011
Decision Date	10/14/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review