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

    BHA100 Series Braun Clear Hearing Aid

    K Number: K212609 · Decision Jan 5, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    6
    Applicant Total
    8
    Review Days
    141

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    Basic Information

    Device Name
    BHA100 Series Braun Clear Hearing Aid
    K Number
    K212609
    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
    Kaz USA, Inc., A Helen of Troy Company
    Date Received
    August 17, 2021
    Decision Date
    January 5, 2022
    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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