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510(k) Data Aggregation

    K Number
    K060194
    Device Name
    MARCH HEALTHCARE HEALTH MONITORING KIT
    Manufacturer
    MARCH HEALTHCARE CORPORATION
    Date Cleared
    2006-02-13

    (19 days)

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

    MARCH HEALTHCARE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Health Monitoring Kit (HMK) is a non-invasive, spot- measuring device used to measure blood pressure, heart rate, oxygen saturation levels, pulse rate, and heart and lung sounds.
    Device Description
    The March Healthcare Health Monitoring Kit (HMK) is a portable medical device equipped with a built-in blood pressure monitor. pulse oximeter, and electronic stethoscope intended for spot-checking the basic vital signs of pediatric patients aged three and older and adult patients under the care of a physician in both clinical and home environments. The HMK can be used as a stand-alone unit or it can be connected to a host using a standard Bluetooth® wireless interface or wired universal serial bus (USB) interface to support remote control of the HMK and audio and data transmission in telehealth applications. In both stand-alone and remote telehealth applications. the user can spot-check the following vital signs with the blood pressure monitor and pulse oximeter: heart rate and svstolic and diastolic blood pressure. and functional blood oxygen saturation and pulse rate. In remote telehealth applications when the HMK is interfaced with a host, the electronic stethoscope transmits heart and lung sounds via the host to a health care professional at a remote computer. The data from the HMK can be viewed in one of two wavs: on the built-in HMK liquid crystal display (LCD) or from a remote computer connected to a host. The HMK blood pressure monitor uses the non-invasive, oscillometric, step-wise deflation method to measure heart rate and systolic and diastolic blood pressure. The noninvasive pulse oximeter measures functional blood oxygen saturation and pulse rate using a photodetector and a red and infrared light source to measure the absorption of red and infrared (IR) light passed through the tissuc and arterial hemoglobin. The electronic stethoscope uses a microphone within the chestpiece. bchind a diaphragm. The microphone converts the sound in the chestpiece to an clectronic signal for amplification and transmission to a health care professional at a remote computer via the host. The HMK does not store physiological data in memory. When using the HMK as a standalone unit. the user must manually record the results displayed on the LCD. However. when the HMK is interfaced with a host, the host may store the audio and physiological data in a database for remote access by authorized clinicians. The HMK is powered with either a Sealed Lead Acid (SLA) battery or a Medical Grade IEC 60601-1 compliant AC adapter. The AC adapter is also used to charge the SLA battery. The HMK has only two external inputs: AC adapter input and universal serial bus (USB) input. The user connects the AC adapter to the DC power plug socket when the battery needs charging. In addition, the user can connect the HMK to the host using the Type B USB input as a wired alternative to the wireless Bluetooth interface. The HMK is for sale by or on the order of a physician.
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