K123796 is an FDA 510(k) clearance for the NEURO OMEGA SYSTEM. This device is classified as a Electrode, Depth (Class II - Special Controls, product code GZL).
Submitted by Alpha Omega Engineering , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on April 5, 2013, 116 days after receiving the submission on December 10, 2012.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1330.
| 510(k) Number | K123796 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2012 |
| Decision Date | April 05, 2013 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GZL - Electrode, Depth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1330 |