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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computerized Cognitive Assessment Aid For Concussion
510(k) Number K201376
Device Name ANAM Test System
Applicant
Vista LifeSciences, Inc.
7375 S. Peoria St. Suite 210
Englewood,  CO  80112
Applicant Contact Margaret E. Molloy
Correspondent
Vista LifeSciences, Inc.
7375 S. Peoria St. Suite 210
Englewood,  CO  80112
Correspondent Contact Margaret E. Molloy
Regulation Number882.1471
Classification Product Code
POM  
Date Received05/26/2020
Decision Date 03/25/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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