The following data is part of a premarket notification filed by Alpha Omega Engineering Ltd. with the FDA for Neuro Omega System, Neurosmart System.
| Device ID | K220553 |
| 510k Number | K220553 |
| Device Name: | Neuro Omega System, NeuroSmart System |
| Classification | Electrode, Depth |
| Applicant | Alpha Omega Engineering Ltd. Hamerkava St.6, Tsiporit Industrial Zone Nof HaGalil (Nazareth Illit), IL 1789062 |
| Contact | Efrat Shamgar |
| Correspondent | Efrat Shamgar Alpha Omega Engineering Ltd. Hamerkava St.6, Tsiporit Industrial Zone Nof HaGalil (Nazareth Illit), IL 1789062 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-28 |
| Decision Date | 2022-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290114064545 | K220553 | 000 |