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

    VERABAND™

    K Number: K233987 · Decision Jun 17, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    182

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    Basic Information

    Device Name
    VERABAND™
    K Number
    K233987
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arbor Medical Innovations, LLC
    Date Received
    December 18, 2023
    Decision Date
    June 17, 2024
    Product Code
    LEL
    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
    LEL Device, Sleep Assessment

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