510(k) K943468 ยท HAW Neurological Stereotaxic Instrument
LEKSELL SURGIPLAN
| Applicant | Elekta Instruments, Inc., Atlanta GA, US |
| Decision | Substantially Equivalent, Jan 20, 1995 |
| Received | Jul 19, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943468
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2010 | Elekta, Inc. Leksell SurgiPlan Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.