The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ensite System, Model Ee3000, And Ensite Navx Surface Electrode, Model En0010.
| Device ID | K083328 |
| 510k Number | K083328 |
| Device Name: | ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ST. JUDE MEDICAL 1350 ENERGY LN., SUITE 110 St. Paul, MN 55108 |
| Contact | Karen Mckelvey |
| Correspondent | Karen Mckelvey ST. JUDE MEDICAL 1350 ENERGY LN., SUITE 110 St. Paul, MN 55108 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-12 |
| Decision Date | 2009-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15414734210000 | K083328 | 000 |
| 05414734210003 | K083328 | 000 |
| 05415067003041 | K083328 | 000 |