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510(k) Data Aggregation

    K Number
    K041169
    Device Name
    PIESOMETER, MODEL MK-1
    Date Cleared
    2004-08-24

    (112 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    CANAMET CANADIAN NATL MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is used to provide data to qualified medical personnel or trained users for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to a 48-hour period. Measurements of systolic, diastolic, and heart rate are made and stored. The device can also be used to provide blood pressure and heart rate data in single measurement mode. The device is also intended to provide preliminary blood pressure data from ambulatory patients for non-time critical applications only. It is for use in hospitals, clinics or physicians offices by a qualified physician or trained staff member under the supervision of that physician. It is also intended for home care use by a trained patient with periodic health consultations from his or her physician. Patient diagnosis is not to be performed solely based on the results of this device.
    Device Description
    The Model PIESOMETER MK-1 Digital Blood Pressure Monitor measures systolic and diastolic blood pressure and heart rate using adaptive interference cancellation (signal processing) technologies. The system employs three acoustic sensors (i.e. microphones) in the electronic pressure cuff. During a blood pressurement, two acoustic sensors are placed in the traditional location on the patient's biceps. This set of sensors, operating much like a conventional stethoscope, senses the Korotkoff sounds. Unique to the PIESOMETER MK-1 is a second set of a sensor placed in the triceps area. This sensor serves to detect any interference signals that would normally compromise the reading. This allows reading to be taken even in noise and vibration intensive environment. This technology functions by identifying signals lying within the audio frequency and filtering out the interference signal. The CANAMET PIESOMETER is protected by U.S. Patent 6,520,918.
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