510(k) K201181 ยท DQK Computer, Diagnostic, Programmable
EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System
| Applicant | ABBOTT MEDICAL, Plymouth MN, US |
| Decision | Substantially Equivalent, Jun 26, 2020 |
| Received | Apr 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201181
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.