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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source Localization Software For Electroencephalograph Or Magnetoencephalograph
510(k) Number K233985
Device Name TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)
Applicant
Megin OY
Keilasatama 5
Espoo,  FI 02150
Applicant Contact Laura Vanonen
Correspondent
RQM+
2790 Mosside Blvd.
Suite 800
Monroeville,  PA  15146
Correspondent Contact Charles Neitzel
Regulation Number882.1400
Classification Product Code
OLX  
Subsequent Product Code
OLY  
Date Received12/18/2023
Decision Date 05/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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