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510(k) Data Aggregation

    K Number
    K071955
    Device Name
    WIM-PC, MODEL 1010
    Manufacturer
    KARMEL SONIX
    Date Cleared
    2007-11-01

    (108 days)

    Product Code
    BZM
    Regulation Number
    868.1900
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    Applicant Name (Manufacturer) :

    KARMEL SONIX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WIM-PCTM is intended for the analysis, interpretation and documentation of lung sounds. The WIM-PC™ is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.
    Device Description
    The WIM-PC™ is a computer based electronic stethoscope that utilizes two contact sensors simultaneously to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays and printed reports. The WIM-PCTM system consists of: Acoustic sensors (attached to the patient using adhesive pads), Sensor pod with a built-in dielectric microphone for ambient noise pick-up, Tension-sensitive respiration belt, A/D data acquisition device, USB cable and signal cable, Laptop PC unit with Data Analysis software.
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