510(k) K160301 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Platinum dRF Imaging System
| Applicant | Apelem-Dms Group, Nimes 30005, FR |
| Decision | Substantially Equivalent, Mar 4, 2016 |
| Received | Feb 4, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160301
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.