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 |
|