FDA 510(k) Application Details - K994011

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K994011
Device Name	Computer, Diagnostic, Programmable
Applicant	EP MEDSYSTEMS, INC. 100 STIERLI CT., SUITE 107 MOUNT ARLINGTON, NJ 07856 US Other 510(k) Applications for this Company
Contact	JOSEPH C GRIFFIN III 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	11/26/1999
Decision Date	03/23/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review