FDA 510(k) Application Details - K033963

Device Classification Name	Catheter, Electrode Recording, Or Probe, Electrode Recording   More FDA Info for this Device
510(K) Number	K033963
Device Name	Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant	EP MEDSYSTEMS, INC. COOPER RUN EXECUTIVE PARK 575 ROUTE 73 NORTH, BUILDING D WEST BERLIN, NJ 08091-9293 US Other 510(k) Applications for this Company
Contact	JAMES E KUHN, JR. Other 510(k) Applications for this Contact
Regulation Number	870.1220   More FDA Info for this Regulation Number
Classification Product Code	DRF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2003
Decision Date	04/15/2004
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