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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pediatric Autism Spectrum Disorder Diagnosis Aid
510(k) Number K260064
Device Name Neurora
Applicant
Argus Cognitive, Inc.
35 S. Main St.
Hanover,  NH  03755
Applicant Contact Andrea Marosan
Correspondent
Argus Cognitive, Inc.
35 S. Main St.
Hanover,  NH  03755
Correspondent Contact Andrea Marosan
Regulation Number882.1491
Classification Product Code
QPF  
Date Received01/09/2026
Decision Date 10/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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