510(k) K221213 ยท DQK Computer, Diagnostic, Programmable
EnSite X EP System
| Applicant | Abbott, St. Paul MN, US |
| Decision | Substantially Equivalent, Aug 18, 2022 |
| Received | Apr 27, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221213
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.