510(k) K171581 ยท GZL Electrode, Depth
Neuro Omega System
| Applicant | Alpha Omega Engineering , Ltd., Nazareth, IL |
| Decision | Substantially Equivalent, Dec 22, 2017 |
| Received | May 31, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171581
| 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.