510(k) K003285 ยท IYE Accelerator, Linear, Medical
EXAC TRAC 2.0 (NOVALIS BODY MODULE)
| Applicant | Brainlab AG, Heimstetten, DE |
| Decision | Substantially Equivalent, Jul 31, 2001 |
| Received | Oct 19, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003285
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.