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510(k) Data Aggregation

    K Number
    K971296
    Device Name
    TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05
    Manufacturer
    NATIONAL HEARING AID DIST., INC.
    Date Cleared
    1997-06-20

    (74 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    NATIONAL HEARING AID DIST., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indications for use of this air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The device(s) is/are indicated for individuals with losses in the following category(ies).
    Device Description
    Tondi BTE Hearing Aid, Models U-2011, U-214, U-03, KA-02, KA-03, KA-UBA, KA-01, KA-04, KA-04A, KA-05
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