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510(k) Data Aggregation

    K Number
    K980878
    Device Name
    PULMOTRACK,MODEL 1010
    Manufacturer
    KARMEL MEDICAL ACOUSTIC TECHNOLOGIES LTD.
    Date Cleared
    1998-12-28

    (294 days)

    Product Code
    BZM
    Regulation Number
    868.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    KARMEL MEDICAL ACOUSTIC TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PulmoTrack Model 1010 is intended for the analysis, interpretation and documentation of lung sounds. The PulmoTrack Model 1010 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 a pulmonary function testing environment when there is a need to perform 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 PulmoTrack is a computer based electronic stethoscope that utilizes up to five 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.
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