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510(k) Data Aggregation

    K Number
    K974219
    Device Name
    FACEPLATE ASSEMBLY
    Date Cleared
    1998-02-20

    (102 days)

    Product Code
    Regulation Number
    874.3300
    Why did this record match?
    Product Code :

    LRB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):
    Device Description
    Finetone ITE Faceplate Assembly, Model M-LIN is a Class A linear circuit. Available options are the Low cut, High cut and Output controls. Finetone ITE Faceplate Assembly, Model M-PP is a Class B circuit. Available options are the Low cut, High cut and ouput controls. Finetone ITE Faceplate Assembly, Model M-HLIN is a Class A linear circuit utilizing a hybrid amplifier. Available options are the Low cut, High cut and Output controls. Finetone ITE Faceplate Assembly, Model M-D is a Class D linear circuit. Available options are the Low cut, High cut and Output controls. Finetone ITE Faceplate Assembly, Model M-D/ASP is a Automatic Signal Processing circuit utilizing Class D technology. Available options are the Asp, Low cut and High cut controls. Finetone ITE Faceplate Assembly, Model M-D/AGCI is an input compression circuit utilizing Class D technology. Available iptions are the Low cut and High cut controls. Finetone ITE Faceplate Assembly, Model M-KAMP detects and amplifies quiet sounds. In loud situations it provides low distortion and high fedelity sound. Available options are the Threshold Kneepoint and low cut controls. Finetone ITE Faceplate Assembly, Model M-EQII is a Wide Dynamic Range, duel channel, input compression circuit which utilizes Class D technology. Available options are the Threshold Kneepoint, Low Frequency Gain, High Frequency Gain, Crossover and Output controls.
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    K Number
    K961593
    Device Name
    INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS
    Date Cleared
    1996-11-07

    (197 days)

    Product Code
    Regulation Number
    874.3300
    Why did this record match?
    Product Code :

    LRB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of these models is to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for impaired hearing.
    Device Description
    Descriptions of the device functions, scientific concepts, and physical and performance characteristics of the above-mentioned Intrastar models are set forth in Attachments 1 and 2.
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