510(k) K172396 ยท DQK Computer, Diagnostic, Programmable
EnSite Velocity Cardiac Mapping System v5.2
| Applicant | St Jude Medical, St. Paul MN, US |
| Decision | Substantially Equivalent, Apr 23, 2018 |
| Received | Aug 8, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172396
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.