510(k) K234080 ยท GWF Stimulator, Electrical, Evoked Response
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
| Applicant | Soterix Medical, Inc., Woodbridge NJ, US |
| Decision | Substantially Equivalent, Mar 25, 2024 |
| Received | Dec 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234080
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.