The following data is part of a premarket notification filed by Alpha Omega Engineering Ltd. with the FDA for Neuro Omega System.
| Device ID | K123796 |
| 510k Number | K123796 |
| Device Name: | NEURO OMEGA SYSTEM |
| Classification | Electrode, Depth |
| Applicant | ALPHA OMEGA ENGINEERING LTD. PO BOX 4414 (A109) Caesarea, IL 30889 |
| Contact | Ilan Sharon |
| Correspondent | Ilan Sharon ALPHA OMEGA ENGINEERING LTD. PO BOX 4414 (A109) Caesarea, IL 30889 |
| Product Code | GZL |
| Subsequent Product Code | GWF |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | IKN |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-10 |
| Decision Date | 2013-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290014954922 | K123796 | 000 |
| 07290014954014 | K123796 | 000 |
| 07290014954021 | K123796 | 000 |
| 17290014954226 | K123796 | 000 |
| 17290014954233 | K123796 | 000 |
| 17290014954240 | K123796 | 000 |
| 07290014954250 | K123796 | 000 |
| 07290014954267 | K123796 | 000 |
| 07290014954274 | K123796 | 000 |
| 07290014954281 | K123796 | 000 |
| 07290014954298 | K123796 | 000 |
| 07290014954304 | K123796 | 000 |
| 07290014954915 | K123796 | 000 |
| 07290014954007 | K123796 | 000 |