FDA 510(k) Application Details - K010638

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K010638
Device Name	Electrode, Cutaneous
Applicant	VERMONT MEDICAL, INC. INDUSTRIAL PARK BELLOWS FALLS, VT 05101 US Other 510(k) Applications for this Company
Contact	MARC FILLION 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	03/05/2001
Decision Date	05/03/2001
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