The following data is part of a premarket notification filed by Alpha Omega Engineering Ltd, with the FDA for Neuro Omega System.
| Device ID | K171581 |
| 510k Number | K171581 |
| Device Name: | Neuro Omega System |
| Classification | Electrode, Depth |
| Applicant | Alpha Omega Engineering Ltd, Nazareth Industrial Park, Mount Precipice, St.2015 Nazareth, IL 1612102 |
| Contact | Maysana Mousa |
| Correspondent | Maysana Mousa Alpha Omega Engineering Ltd, Nazareth Industrial Park, Mount Precipice, St.2015 Nazareth, IL 1612102 |
| Product Code | GZL |
| Subsequent Product Code | GWF |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | GYC |
| Subsequent Product Code | IKN |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-31 |
| Decision Date | 2017-12-22 |
| Summary: | summary |