FDA device listing
Autoclavable Drive,NeuroFortis Neuro Omega Drive Headstage,Neuro Omega,Neuro Omega Autoclavable Drive Headstage,Neuro…
FDA device listing 1571962477 · ALPHA OMEGA ENGINEERING LTD.
Key facts
| Proprietary names | Autoclavable Drive,NeuroFortis Neuro Omega Drive Headstage,Neuro Omega,Neuro Omega Autoclavable Drive Headstage,Neuro Omega Drive Headstage,Neuro Omega ECOG HeadBox Kit,Neuro Omega EMG HeadBox Kit,Neuro Omega MER Headstage,Neuro Omega with NeuroFortis drive + 1 basic stimulation Slot,Neuro Omega with NeuroFortis drive + 2 basic stimulation Slots,Neuro Omega with Neuro Omega drive + 1 basic… |
|---|---|
| Owner/operator | ALPHA OMEGA ENGINEERING LTD. |
| Owner/operator number | 9039414 |
| Premarket submissions | K171581 |
| Product codes | GWF, GWQ, GYC, GZL, IKN |
| Device names | GWF - Stimulator, Electrical, Evoked Response, GWQ - Full-Montage Standard Electroencephalograph, GYC - Electrode, Cortical, GZL - Electrode, Depth, IKN - Electromyograph, Diagnostic |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.1310, 882.1330, 882.1400, 882.1870, 890.1375 |
| Review panels | Neurology, Physical Medicine |
| Registered establishments | ALPHA OMEGA ENGINEERING LTD. |
| Establishment registrations | 9615126 |
| FEI numbers | 3001610756 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database