510(k) K160210 ยท DQK Computer, Diagnostic, Programmable
EnSite Precision Cardiac Mapping System v2.0
| Applicant | St Jude Medical, St. Paul MN, US |
| Decision | Substantially Equivalent, Dec 13, 2016 |
| Received | Jan 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160210
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.