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    K Number
    K971852
    Device Name
    AIR CONDUCTION HAEARING AIDS
    Manufacturer
    BELTONE ELECTRONICS CORP.
    Date Cleared
    1997-08-15

    (87 days)

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

    BELTONE ELECTRONICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). Severity: Slight, Mild, Moderate, Severe, Profound Configuration: 1. High Frequency - Precipitously Sloping, 2. Gradually Sloping, 3. Reverse Slope, 4. Flat Other: Low tolerance To Loudness
    Device Description
    The ITE, ITC, and CIC air conduction hearing aids are devices previously given marketing approval by the FDA. Beltone will be adding a new circuit option, GM-3036 manufactured by Gennum, to each of the models and will market this circuit option under the name CSP II Programmable.
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    K Number
    K963958
    Device Name
    IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT
    Manufacturer
    BELTONE ELECTRONICS CORP.
    Date Cleared
    1996-12-05

    (64 days)

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

    BELTONE ELECTRONICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K955930
    Device Name
    BELTONE COMPOSER 2000 BTE HP
    Manufacturer
    BELTONE ELECTRONICS CORP.
    Date Cleared
    1996-03-01

    (71 days)

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

    BELTONE ELECTRONICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To amplify and transmit sound to the ear
    Device Description
    The Beltone Composer 2000 BTE HP Air Conduction Hearing Aid is identical to the Maico Gamma RD BTE HP programmable hearing aid (K933291) with the exception of changes to the labeling.
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