The following data is part of a premarket notification filed by Ep Medsystems, Inc. with the FDA for Ep Medsystems, Ep-workmate.
| Device ID | K994011 |
| 510k Number | K994011 |
| Device Name: | EP MEDSYSTEMS, EP-WORKMATE |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | EP MEDSYSTEMS, INC. 100 STIERLI CT., SUITE 107 Mount Arlington, NJ 07856 |
| Contact | Joseph C Griffin Iii |
| Correspondent | Joseph C Griffin Iii EP MEDSYSTEMS, INC. 100 STIERLI CT., SUITE 107 Mount Arlington, NJ 07856 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-26 |
| Decision Date | 2000-03-23 |