510(k) K091457 ยท GWF Stimulator, Electrical, Evoked Response
NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM
| Applicant | Nexstim OY, North Attleboro MA, US |
| Decision | Substantially Equivalent, Dec 8, 2009 |
| Received | May 18, 2009 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K091457
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2017 | Nexstim PLC Nexstim eXima NBS System Software version 2.2 or higher.
The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to i Open, Classified |
GWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.