The following data is part of a premarket notification filed by Ep Medical, Inc. with the FDA for Model Ep-2 Clinical Stimulator.
| Device ID | K933069 |
| 510k Number | K933069 |
| Device Name: | MODEL EP-2 CLINICAL STIMULATOR |
| Classification | Tester, Pacemaker Electrode Function |
| Applicant | EP MEDICAL, INC. 54 ROUTE 46 WEST Budd Lake, NJ 07828 |
| Contact | David Jenkins |
| Correspondent | David Jenkins EP MEDICAL, INC. 54 ROUTE 46 WEST Budd Lake, NJ 07828 |
| Product Code | DTA |
| CFR Regulation Number | 870.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-22 |
| Decision Date | 1993-10-21 |