BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER

    K Number: K970340 · Decision Mar 26, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    56

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    Basic Information

    Device Name
    AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER
    K Number
    K970340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3320
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bellab
    Date Received
    January 29, 1997
    Decision Date
    March 26, 1997
    Product Code
    LZI
    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
    LZI Device, Assistive Listening

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