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510(k) Data Aggregation

    K Number
    K082771
    Device Name
    PROTRON TECHNOLOGIES, LLC STETHOTRON
    Date Cleared
    2009-02-27

    (158 days)

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

    PROTRON TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ProTron Technologies, Electronic Stethoscope, Model Stethotron is intended for medical diagnostic purpose only. Stethotron has two modes of operation, amplification with filtering (Mode 1) and amplification only (Mode 2). Mode 1 filters out sounds below 350 Hz and above 1,000 Hz and used to listen specifically for vascular pathology. Mode 2 is used to listen for heart, lung, arteries, and other body sounds from 20 Hz to 20,000 Hz during routine physical examinations. Stethotron can be used on adult or paediatric patients undergoing physical examination.
    Device Description
    The ProTron Technologies, LLC Electronic Stethoscope, Model Stethotron is a battery powered analog device with two user selectable modes of operation for detecting, amplifying and filtering various body sounds of the heart, lungs, arteries, and internal organs: Mode 1 filters out sounds below 350 Hz and above 1,000 Hz. Mode 2 provides amplification only, 20 Hz to 20,000 Hz. Stethotron has volume controls on both modes enabling the user to adjust the sound to the level desired. The chestpiece of the device is sized for use with adult or pediatric patients and is a bell and diaphragm design incorporating a microphone. All of the electronics are contained in a plastic casing positioned below the bifurcation of the stethoscope yoke that connects to the headset that terminates at the eartips. The electronic casing includes the ON/OFF switch, volume control, and mode of operation selection control on the face. It is powered by two AAA alkaline batteries.
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