K233985 is an FDA 510(k) clearance for the TRIUX™ neo (NM27000N ). This device is classified as a Source Localization Software For Electroencephalograph Or Magnetoencephalograph (Class II - Special Controls, product code OLX).
Submitted by Megin OY (Espoo, FI). The FDA issued a Cleared decision on May 15, 2024, 149 days after receiving the submission on December 18, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization.
| 510(k) Number | K233985 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2023 |
| Decision Date | May 15, 2024 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OLX - Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization |