510(k) K192102 ยท IYE Accelerator, Linear, Medical
Thermoplastic Masks
| Applicant | Aktina Medical Corporation, Congers NY, US |
| Decision | Substantially Equivalent, Sep 25, 2019 |
| Received | Aug 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192102
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.