510(k) K191158 ยท IYE Accelerator, Linear, Medical
The AIO Solution
| Applicant | Orfit Industries NV, Wijnegem, BE |
| Decision | Substantially Equivalent, Aug 6, 2019 |
| Received | May 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191158
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.