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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 K243558
Device Name Canvas Dx
Applicant
Cognoa, Inc.
2185 Park Blvd.
Palo Alto,  CA  94306
Applicant Contact Sharief Taraman
Correspondent
RQM+
2790 Mosside Blvd. #800
Monroeville,  PA  15146
Correspondent Contact Alexia Haralambous
Regulation Number882.1491
Classification Product Code
QPF  
Date Received11/18/2024
Decision Date 04/11/2025
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		 Yes
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