510(k) K001437 ยท DQK Computer, Diagnostic, Programmable
ENSITE 3000 SYSTEM, MODEL EE3000
| Applicant | Endocardial Solutions, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Jun 7, 2000 |
| Received | May 8, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001437
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.