FDA 510(k) Application Details - K971914

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K971914
Device Name	Electrode, Cutaneous
Applicant	MEDELEC, INC. D.B.A. TECA CORP. 3 CAMPUS DR. PLEASANTVILLE, NY 10570 US Other 510(k) Applications for this Company
Contact	JAMES P HURLMAN 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	05/23/1997
Decision Date	03/26/1998
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