510(k) K183128 ยท DQK Computer, Diagnostic, Programmable
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
| Applicant | Abbott, St. Paul MN, US |
| Decision | Substantially Equivalent, Dec 12, 2018 |
| Received | Nov 13, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183128
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.