The following data is part of a premarket notification filed by Ep Medsystems with the FDA for Ep-workmate With Rpm System.
| Device ID | K032225 |
| 510k Number | K032225 |
| Device Name: | EP-WORKMATE WITH RPM SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | EP MEDSYSTEMS COOPER RUN EXECUTIVE PARK 575 ROUTE 73 N. BLDG. D West Berlin, NJ 08091 |
| Contact | James E Kuhn |
| Correspondent | James E Kuhn EP MEDSYSTEMS COOPER RUN EXECUTIVE PARK 575 ROUTE 73 N. BLDG. D West Berlin, NJ 08091 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-21 |
| Decision Date | 2003-08-20 |