K171581 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. (Nazareth, IL). The FDA issued a Cleared decision on December 22, 2017, 205 days after receiving the submission on May 31, 2017.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1330.
| 510(k) Number | K171581 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2017 |
| Decision Date | December 22, 2017 |
| Days to Decision | 205 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZL - Electrode, Depth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1330 |