FDA 510(k) Application Details - K013349

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K013349
Device Name	Computer, Diagnostic, Programmable
Applicant	EP TECHNOLOGIES, INC. 2710 ORCHARD PKWY. SAN JOSE, CA 95134 US Other 510(k) Applications for this Company
Contact	ANDREA L RUTH 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	10/09/2001
Decision Date	04/09/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review