510(k) K213479 · OWB Interventional Fluoroscopic X-Ray System
D²RS and D²RS 9090
| Applicant | Stephanix, La Ricamarie, FR |
| Decision | Substantially Equivalent, Dec 23, 2021 |
| Received | Oct 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213479
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.