510(k) K970384 ยท IYE Accelerator, Linear, Medical
VELOS CONSTANCY CHECK DEVICE, MODEL 55-145
| Applicant | Aktina Medical Physics Corp., Congers NY, US |
| Decision | Substantially Equivalent, Jul 29, 1997 |
| Received | Feb 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970384
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.