510(k) K021338 ยท IYE Accelerator, Linear, Medical
ACCULEAF
| Applicant | Direx Systems Corp., Natick MA, US |
| Decision | Substantially Equivalent, Jan 7, 2003 |
| Received | Apr 26, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021338
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.