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

    Insight Infrared Video Goggles

    K Number: K203082 · Decision Nov 12, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    58
    Applicant Total
    1
    Review Days
    30

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    Basic Information

    Device Name
    Insight Infrared Video Goggles
    K Number
    K203082
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vestibular First
    Date Received
    October 13, 2020
    Decision Date
    November 12, 2020
    Product Code
    GWN
    Advisory Committee
    Neurology
    Review Advisory Committee
    EN
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    GWN Nystagmograph

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