510(k) K060954 ยท DQK Computer, Diagnostic, Programmable
MODIFICATION TO ENSITE SYSTEM, MODEL EE3000
| Applicant | St. Jude Medical, Inc.-Endocardial Solutions, St. Paul MN, US |
| Decision | Substantially Equivalent, Apr 21, 2006 |
| Received | Apr 7, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060954
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.