ANAM Test System

Computerized Cognitive Assessment Aid For Concussion

Vista LifeSciences, Inc.

The following data is part of a premarket notification filed by Vista Lifesciences, Inc. with the FDA for Anam Test System.

Pre-market Notification Details

Device IDK201376
510k NumberK201376
Device Name:ANAM Test System
ClassificationComputerized Cognitive Assessment Aid For Concussion
Applicant Vista LifeSciences, Inc. 7375 S. Peoria St. Suite 210 Englewood,  CO  80112
ContactMargaret E. Molloy
CorrespondentMargaret E. Molloy
Vista LifeSciences, Inc. 7375 S. Peoria St. Suite 210 Englewood,  CO  80112
Product CodePOM  
CFR Regulation Number882.1471 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-26
Decision Date2021-03-25

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