BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)

    K Number: K223694 · Decision Jun 30, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    76
    Applicant Total
    1
    Review Days
    203

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    Basic Information

    Device Name
    Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)
    K Number
    K223694
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3400
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Duearity AB
    Date Received
    December 9, 2022
    Decision Date
    June 30, 2023
    Product Code
    KLW
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KLW Masker, Tinnitus

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