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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K261604
Device Name Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)
Applicant
Neuroelectrics Barcelona S.L.U.
Av. Tibidabo, 47 Bis
Barcelona,  ES 08035
Applicant Contact Ana Maiques
Correspondent
Neuroelectrics Barcelona S.L.U.
Av. Tibidabo, 47 Bis
Barcelona,  ES 08035
Correspondent Contact Ana Maiques
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Codes
GWL   GXY  
Date Received05/14/2026
Decision Date 06/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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