The following data is part of a premarket notification filed by Ep Medsystems with the FDA for Modification Of Procath Electrophysiology Catheter, Ep Medsystems Electrophysiology Catheter.
| Device ID | K991001 |
| 510k Number | K991001 |
| Device Name: | MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | EP MEDSYSTEMS COOPER RUN EXECUTIVE PARK 575 RT. 73 NORTH, BLDG. D West Berlin, NJ 08091 |
| Contact | Joseph C Griffin, Iii |
| Correspondent | Joseph C Griffin, Iii EP MEDSYSTEMS COOPER RUN EXECUTIVE PARK 575 RT. 73 NORTH, BLDG. D West Berlin, NJ 08091 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-25 |
| Decision Date | 1999-07-15 |