510(k) K010449 ยท IYE Accelerator, Linear, Medical
IVD (IN VIVO DOSIMETER), MODEL 1131
| Applicant | Sun Nuclear Corp., Melbourne FL, US |
| Decision | Substantially Equivalent, May 4, 2001 |
| Received | Feb 15, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010449
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.