510(k) K083328 ยท DQK Computer, Diagnostic, Programmable
ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010
| Applicant | St Jude Medical, St. Paul MN, US |
| Decision | Substantially Equivalent, May 22, 2009 |
| Received | Nov 12, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083328
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.