FDA 510(k) Application Details - K001521

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K001521
Device Name	Electrode, Cutaneous
Applicant	INTEGRATED BIOSENSING TECHNOLOGIES 86 BOSTON POST RD. WATERFORD, CT 06385 US Other 510(k) Applications for this Company
Contact	RONALD LUICH 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	05/16/2000
Decision Date	11/27/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review