510(k) K250601 ยท GZL Electrode, Depth
Neuro Omega System; NeuroSmart System
| Applicant | Alpha Omega Engineering , Ltd., Nof Hagalil (Nazareth Illit), IL |
| Decision | Substantially Equivalent, Mar 30, 2025 |
| Received | Feb 28, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250601
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.