Submission Details
| 510(k) Number | K233985 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
TRIUX? neo (NM27000N ); MEGreview (SW26241N-B)
May 2024
Decision
149d
Days
Class 2
Risk
About This 510(k) Submission
K233985 is an FDA 510(k) clearance for the TRIUX? neo (NM27000N ); MEGreview (SW26241N-B), 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 review panel. Regulated under 21 CFR 882.1400.
Device Classification
| 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 |
Manufacturer
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