510(k) K213439 ยท IYE Accelerator, Linear, Medical
FlexBoardTM, EagleBoardTM, BreastBoard SXTM
| Applicant | Macromedics BV, Moordrecht, NL |
| Decision | Substantially Equivalent, Jun 24, 2022 |
| Received | Oct 25, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213439
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.