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

    EYE-SYNC

    K Number: K202927 · Decision Oct 2, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    368

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    Basic Information

    Device Name
    EYE-SYNC
    K Number
    K202927
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1455
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Syncthink, Inc.
    Date Received
    September 29, 2020
    Decision Date
    October 2, 2021
    Product Code
    QEA
    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
    QEA Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

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    Other Clearances by Syncthink, Inc.

    K Number Device Name
    K152915 EYE-SYNC