The following data is part of a premarket notification filed by Ep Medsystems with the FDA for Ep-workmate.
| Device ID | K063113 |
| 510k Number | K063113 |
| Device Name: | EP-WORKMATE |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | EP MEDSYSTEMS COOPER RUN EXECUTIVE PARK 575 ROUTE 73 N. BLDG. D West Berlin, NJ 08091 |
| Contact | Larry Picciano |
| Correspondent | Larry Picciano 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 | 2006-10-11 |
| Decision Date | 2006-10-27 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EP-WORKMATE 75325657 2225246 Live/Registered |
St. Jude Medical, Atrial Fibrilation Div 1997-07-17 |