510(k) K102765 ยท IYE Accelerator, Linear, Medical
PRONEX
| Applicant | Direx Systems Corp., Canton MA, US |
| Decision | Substantially Equivalent, Dec 7, 2010 |
| Received | Sep 24, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102765
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.