510(k) K221335 · OWB Interventional Fluoroscopic X-Ray System
D²RS and D²RS 9090
| Applicant | Stephanix, La Ricamarie, FR |
| Decision | Substantially Equivalent, Jun 7, 2022 |
| Received | May 9, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K221335
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.