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510(k) Data Aggregation

    K Number
    K970537
    Device Name
    REXTON MODEL 48 AND 49PP
    Manufacturer
    REXTON, INC.
    Date Cleared
    1997-03-28

    (44 days)

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

    REXTON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To amplify and transmit sound to the ear.
    Device Description
    Both the 48 and the 49PP are small slim-lined body aids. Their unique shape fits snugly and inconspicuously into any pocket or other places,e.g. brasiere etc. The 48 and the 49PP both have audio input that allows the connection to external sources. Also both have 3 position switch for off-telecoil-microphone. Assembled from standard components which are widely utilized by other hearing aid manufacturers.
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    K Number
    K964451
    Device Name
    PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC
    Manufacturer
    REXTON, INC.
    Date Cleared
    1996-11-27

    (21 days)

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

    REXTON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To amplify and transmit sound to the ear.
    Device Description
    The Piccolo series of BTE's are a small compact hearing aid. It has incorporated in it's package a very slim housing that can be worn with glasses. The use of the new modern and small receiver enables the integrated amplifier to have better battery life with less distortion.The aid also has AGC-I, active low frequency tone control and a three position, rotating switch for Off-Telecoil-Microphone.
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    K Number
    K960295
    Device Name
    LONG LIFE RX-12
    Manufacturer
    REXTON, INC.
    Date Cleared
    1996-03-22

    (60 days)

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

    REXTON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To amplify and transmit sound to the ear.
    Device Description
    The Rexton Long Life Rx-12 is a full shell hearing aid utilizing a 675 battery and a low drain class D circuit. The combination of these to unique features gives the Rexton Long Life the ease of battery handling (a large 675 battery) and the benifits of extended battery life. These two features should make for a special product with-in the industry. Assembled from standard components which are widely utilized by other hearing aid manufacturers.
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    K Number
    K954922
    Device Name
    REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTS
    Manufacturer
    REXTON, INC.
    Date Cleared
    1996-01-17

    (83 days)

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

    REXTON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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