510(k) K212909 ยท IYE Accelerator, Linear, Medical
VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips
| Applicant | Macromedics BV, Moordrecht, NL |
| Decision | Substantially Equivalent, May 11, 2022 |
| Received | Sep 13, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212909
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.