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 |