510(k) K201148 ยท DQK Computer, Diagnostic, Programmable
EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License
| Applicant | ABBOTT MEDICAL, St. Paul MN, US |
| Decision | Substantially Equivalent, Jun 26, 2020 |
| Received | Apr 29, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201148
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.