K234080 is an FDA 510(k) clearance for the MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S). This device is classified as a Stimulator, Electrical, Evoked Response (Class II - Special Controls, product code GWF).
Submitted by Soterix Medical, Inc. (Woodbridge, US). The FDA issued a Cleared decision on March 25, 2024, 94 days after receiving the submission on December 22, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1870.
| 510(k) Number | K234080 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2023 |
| Decision Date | March 25, 2024 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWF - Stimulator, Electrical, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1870 |