K220553 is an FDA 510(k) clearance for the Neuro Omega System, NeuroSmart System. This device is classified as a Electrode, Depth (Class II - Special Controls, product code GZL).
Submitted by Alpha Omega Engineering , Ltd. (Nof Hagalil (Nazareth Illit), IL). The FDA issued a Cleared decision on September 16, 2022, 200 days after receiving the submission on February 28, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1330.
| 510(k) Number | K220553 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2022 |
| Decision Date | September 16, 2022 |
| Days to Decision | 200 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZL - Electrode, Depth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1330 |