BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ANAM Test System

    K Number: K201376 · Decision Mar 25, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    303

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    Basic Information

    Device Name
    ANAM Test System
    K Number
    K201376
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1471
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vista Lifesciences, Inc.
    Date Received
    May 26, 2020
    Decision Date
    March 25, 2021
    Product Code
    POM
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    POM Computerized Cognitive Assessment Aid For Concussion

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