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510(k) Data Aggregation

    K Number
    K031446
    Device Name
    JABES ELECTRONIC STETHOSCOPE
    Manufacturer
    GS TECHNOLOGY CO., LTD.
    Date Cleared
    2003-10-31

    (177 days)

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

    GS TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JABES Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.
    Device Description
    The JABES Electronic Stethoscope is intended for use as a diagnostic aid in patients diagnosis, treatment and monitoring. It provides three filter frequency modes: Bell (20-200Hz), Diaphragm (200-500Hz). Wide (20-800Hz). Bell Mode is similar to the acoustic bell-type stethoscope and optimized for heart and other cardiology related sound. Diaphragm Mode is similar to the acoustic diaphragm-type stethoscope and optimized for higher pitched sound such as lung and bronchial sounds. Wide Mode is a combination of Bell and Diaphragm Modes. Wide Mode provides wider frequency range compare to the typical acoustic stethoscope including the Bell-type and Diaphragm-type. The JABES amplifies sounds up to 18 times bigger than an ordinary acoustic stethoscope in a broad frequency range, including a range higher than the traditional diaphragm mode. It looks similar to the traditional stethoscope including parts like a diaphragm, binaural pipes and ear tips. However, it has four (4) buttons on top of the chest set (opposite to the diaphragm side). Each of the buttons has a function of controlling the modes, volume up/down and power on/off. As an electronic stethoscope, it needs two (2) batteries (AAA type, 1.5V) to operate. The stethoscope has power saving functions for longer battery life and has a low battery indicator to prevent the use in malfunctioning condition due to the low power.
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