510(k) K160350 ยท JAK System, X-Ray, Tomography, Computed
ECG CT Gating Device
| Applicant | Neocoil, LLC, Pewaukee WI, US |
| Decision | Substantially Equivalent, Jun 16, 2016 |
| Received | Feb 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160350
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.