The following data is part of a premarket notification filed by Ep Medical, Inc. with the FDA for Ep Medical, Inc. Ep-3 Clinical Stimulator.
| Device ID | K935590 |
| 510k Number | K935590 |
| Device Name: | EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR |
| Classification | Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) |
| Applicant | EP MEDICAL, INC. 58 ROUTE 46 WEST Budd Lake, NJ 07828 |
| Contact | David A Jenkins |
| Correspondent | David A Jenkins EP MEDICAL, INC. 58 ROUTE 46 WEST Budd Lake, NJ 07828 |
| Product Code | JOQ |
| CFR Regulation Number | 870.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-18 |
| Decision Date | 1994-05-05 |