510(k) K213455 ยท OWB Interventional Fluoroscopic X-Ray System
ControlRad Select Model Z
| Applicant | Controlrad, Inc., Norcross GA, US |
| Decision | Substantially Equivalent, Nov 24, 2021 |
| Received | Oct 26, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213455
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.