FDA 510(k) Application Details - K012089

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K012089
Device Name	Computer, Diagnostic, Programmable
Applicant	CATHEFFECTS, LLC. 1100 MELODY LANE; SUITE 108 ROSEVILLE, CA 95678 US Other 510(k) Applications for this Company
Contact	SHAWN FOJTIK Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2001
Decision Date	01/28/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review