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

    Lumen 155-SF

    K Number: K223911 · Decision Oct 17, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    292

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    Basic Information

    Device Name
    Lumen 155-SF
    K Number
    K223911
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3325
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intricon Corporation
    Date Received
    December 29, 2022
    Decision Date
    October 17, 2023
    Product Code
    QDD
    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
    QDD Self-Fitting Air-Conduction Hearing Aid, Prescription

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