The following data is part of a premarket notification filed by Ep Medsystems with the FDA for Ep-4 Clinical Stimulator.
| Device ID | K040207 |
| 510k Number | K040207 |
| Device Name: | EP-4 CLINICAL STIMULATOR |
| Classification | Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) |
| Applicant | EP MEDSYSTEMS COOPER RUN EXECUTIVE PARK 575 RT. 73 NORTH, BLDG. D West Berlin, NJ 08091 |
| Contact | James E Kuhn |
| Correspondent | James E Kuhn EP MEDSYSTEMS COOPER RUN EXECUTIVE PARK 575 RT. 73 NORTH, BLDG. D West Berlin, NJ 08091 |
| Product Code | JOQ |
| CFR Regulation Number | 870.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-30 |
| Decision Date | 2004-02-27 |