510(k) K213364 ยท DQK Computer, Diagnostic, Programmable
EnSite X EP System
| Applicant | ABBOTT MEDICAL, Plymouth MN, US |
| Decision | Substantially Equivalent, Nov 11, 2021 |
| Received | Oct 12, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213364
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.