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510(k) Data Aggregation

    K Number
    K070550
    Device Name
    AUSCO ES-3100
    Date Cleared
    2007-11-06

    (252 days)

    Product Code
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    KORATEK COMPANY, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AUSCO ES-3100 Electronic Stethoscope is intended for medical diagnostic purposes. It may be used for the amplification of sounds associated with the heart, lungs, arteries, veins, and other internal organs. It can be used on any person undergoing a physical assessment.
    Device Description
    The AUSCO ES-3100 Electronic Stethoscope is a healthcare device that electronically filters and amplifies sounds of the heart, lungs, arteries, veins and other internal organs, and transfers them to the user's ears through an active speaker and passive sound tubes. The AUSCO ES-3100 provides two filter frequency modes for auscultation: Bell (20 to 200Hz) and Diaphragm (20 to 1000Hz). The AUSCO ES-3100 incorporates electronics and embedded software, which controls all of the various features such as volume control, frequency mode selection, and automatic powering off of the stethoscope. Active high and low pass filtering circuits are employed to produce the bell and diaphragm frequency response modes that are used to listen to the heart, lungs and other body sounds, while reducing frictional noises. The AUSCO ES-3100 does not employ any off-the-shelf-software. The AUSCO ES-3100 uses two (2) AAA alkaline batteries.
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