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510(k) Data Aggregation

    K Number
    K062481
    Device Name
    SERENO ELECTRONIC STETHOSCOPE
    Manufacturer
    PISHON HIGH TECH CO., LTD.
    Date Cleared
    2006-10-16

    (53 days)

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

    PISHON HIGH TECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SERENO 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 SERENO electronic stethoscope is intended for use as a diagnostic aid in patient diagnosis and monitoring. The SERENO electronic stethoscope amplifies sounds up to 20 times bigger than 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 probe head, binaural pipes and ear tips. It has four (4) buttons on the top of the chest set (opposite to the probe). 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 automatic power off function for longer battery life and has a LCD display to show volume level, frequency mode and low battery indicator. With the enclosed audio cable. utilizing a personal computer, the user can store sound signals in the PC and transmit diagnosis data via e-mail. This stethoscope is a stand-alone unit, has no software and operates using an analog audio system with a digital timer for power saving and a digital control for the volume and the filter mode selection. It can be connected to audio input of a sound card in a computer to use the PC software functions. However, the software does not operate nor control the stethoscope in any manner. In fact, the stethoscope's audio output can be connected to any ordinary audio equipment such as a cassette recorder, a hi-fi audio component and portable audio.
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