510(k) K123796 ยท GZL Electrode, Depth
NEURO OMEGA SYSTEM
| Applicant | Alpha Omega Engineering , Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, Apr 5, 2013 |
| Received | Dec 10, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123796
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2019 | Alpha Omega Engineering Neuro Omega System, incorporating HaGuide software.
For neurological and neurosurgical use.
To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue. Terminated |
GZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.