510(k) K212061 ยท DQK Computer, Diagnostic, Programmable
EnSite X EP System
| Applicant | Abbott, St. Paul MN, US |
| Decision | Substantially Equivalent, Oct 22, 2021 |
| Received | Jul 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212061
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.