510(k) K231055 · EHD Unit, X-Ray, Extraoral With Timer
x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)
| Applicant | De Götzen S.R.L., Fagnano Olona, IT |
| Decision | Substantially Equivalent, Dec 28, 2023 |
| Received | Apr 13, 2023 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K231055
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.