510(k) K233985
K233985 is an FDA 510(k) premarket notification submitted by Megin OY for the device "TRIUX neo (NM27000N ); MEGreview (SW26241N-B)". The FDA issued a decision of Substantially Equivalent on May 15, 2024. The device falls under product code OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph), a Class II device regulated under 21 CFR 882.1400.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 2024
- Date Received
- December 18, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Source Localization Software For Electroencephalograph Or Magnetoencephalograph
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- NE
- Submission Type
Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization