510(k) K220553 ยท GZL Electrode, Depth
Neuro Omega System, NeuroSmart System
| Applicant | Alpha Omega Engineering , Ltd., Nof Hagalil (Nazareth Illit), IL |
| Decision | Substantially Equivalent, Sep 16, 2022 |
| Received | Feb 28, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K220553
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.