The following data is part of a premarket notification filed by St. Jude Medical, Inc.-endocardial Solutions with the FDA for Modification To Ensite System, Model Ee3000.
| Device ID | K060954 |
| 510k Number | K060954 |
| Device Name: | MODIFICATION TO ENSITE SYSTEM, MODEL EE3000 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ST. JUDE MEDICAL, INC.-ENDOCARDIAL SOLUTIONS 1350 ENERGY LN., SUITE 110 St. Paul, MN 55108 -5254 |
| Contact | Karen J Mckelvey |
| Correspondent | Karen J Mckelvey ST. JUDE MEDICAL, INC.-ENDOCARDIAL SOLUTIONS 1350 ENERGY LN., SUITE 110 St. Paul, MN 55108 -5254 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-07 |
| Decision Date | 2006-04-21 |
| Summary: | summary |