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510(k) Data Aggregation

    K Number
    K970340
    Device Name
    AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER
    Manufacturer
    BELLAB
    Date Cleared
    1997-03-26

    (56 days)

    Product Code
    LZI
    Regulation Number
    874.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    BELLAB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To assist in conversation, meetings and TV-listening by amplifying sound. The indications for use of the assistive listening device in this submission is to amplify-sound for individuals with impaired-hearing. The device is indicated for individuals with hearing loss in the following category(ies). Severity: Mild, Moderate Configuration: Gradually Sloping, Flat
    Device Description
    Air Conduction Assistive Listening Device. Personal Amplifier. Features: Adjustable volume control, Microphone/Telephone/Off switch, Gain, Treble and AGC adjustment trimmers, Internal/External microphone switch. Assembly: Assembled from standard components widely used in electronic products. Technical Characteristics: Technical specifications comply with ANSI S3.22-1987. Controls: Volume control, Microphone/Telephone/Off switch, Internal/External microphone switch and sound adjustment trimmers similar to those used on other assistive listening devices/Personal amplifiers. Power: Standard alkaline AAA (or LR03) size battery.
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