510(k) K033211 ยท DQK Computer, Diagnostic, Programmable
ENSITE SYSTEM
| Applicant | Endocardial Solutions, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Oct 30, 2003 |
| Received | Oct 3, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033211
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.