510(k) K112881 ยท GWF Stimulator, Electrical, Evoked Response
NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
| Applicant | Nexstim OY, Helsinki, FI |
| Decision | Substantially Equivalent, May 22, 2012 |
| Received | Sep 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112881
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2017 | Nexstim PLC NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1.
The Nexstim Navigated Brain Stimulation System (NBS System) is Open, Classified |
GWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.