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

    Q-Collar

    K Number: DEN200017 · Decision Feb 26, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    344

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    Basic Information

    Device Name
    Q-Collar
    K Number
    DEN200017
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    890.3050
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Q30 Sports Science, LLC
    Date Received
    March 19, 2020
    Decision Date
    February 26, 2021
    Product Code
    QNX
    Advisory Committee
    Neurology
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QNX External Compression Device For Internal Jugular Vein Compression