FDA 510(k) Application Details - K042384

Device Classification Name	Electrode, Depth   More FDA Info for this Device
510(K) Number	K042384
Device Name	Electrode, Depth
Applicant	CYBERKINETICS, INC. (CKI) 391 CHIPETA WAY SUITE G SALT LAKE CITY, UT 84108 US Other 510(k) Applications for this Company
Contact	BURKE T BARRETT Other 510(k) Applications for this Contact
Regulation Number	882.1330   More FDA Info for this Regulation Number
Classification Product Code	GZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/2004
Decision Date	03/29/2005
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