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510(k) Data Aggregation

    K Number
    K011842
    Device Name
    SABRE COMPAC
    Manufacturer
    SLE LIMITED
    Date Cleared
    2002-01-08

    (210 days)

    Product Code
    GWJ
    Regulation Number
    882.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    SLE LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SABRe Compac Auditory Brainstem Response Screener is a device that produces a sound stimulus for use in evoked response measurements. It is intended to be used by trained professionals in the determination of hearing disorders.
    Device Description
    The SABRe Compac ABR Screener is an evoked potential device to be used in the diagnosis of hearing disorders.
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    K Number
    K993177
    Device Name
    SABRE
    Manufacturer
    SLE LIMITED
    Date Cleared
    1999-11-16

    (85 days)

    Product Code
    GWJ
    Regulation Number
    882.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    SLE LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SABRE Auditory Brainstem Response Screener is a device that produces a sound stimulus for use in evoked response measurements. It is intended to be used by trained professionals in the evaluation of hearing function.
    Device Description
    The SABRE ABR Screener is an evoked potential device to be used in the evaluation of hearing function.
    Ask a Question

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