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510(k) Data Aggregation

    K Number
    K142476
    Device Name
    Master Caution Device MCD
    Manufacturer
    HealthWatch Ltd.
    Date Cleared
    2015-02-17

    (167 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    HealthWatch Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Master Caution Device (MCD) is intended to condition an electrocardiographic signal, so that it can be transmitted digitally via Bluetooth technology and cell-phone or communication device to a remote location. The Master Caution Device (MCD) is designed to be used by a patient to transmit a 12 lead ECG, posture and motion , respiration and skin temperature (IR) signals, in near real-time to enable review at a physician's office, hospital or other remote medical receiving center. Master Caution Device (MCD) target population is adults above the age of 21.
    Device Description
    The HealthWatch Master Caution Device (MCD) is a personal, hand-held battery powered, ECG device that can be connected to any approved and market cleared, ten standard ECG electrodes, configuring a 12-lead ECG device. The MCD is a miniature ECG device with an embedded processor containing data acquisition, data storage, data processing accelerometers, respiration, skin temperature (IR) and BT (Bluetooth) capabilities. The HealthWatch Master Caution Device (MCD) acquires ECG data via the connected electrodes. The HealthWatch Master Caution Device (MCD) transmits the data in near real time to a suitable Bluetooth communication device for forwarding to a remote location for professional review. A communication device is defined as any device that is capable of receiving the ECG data via Bluetooth and forwarding it via WIFI or cellular network (3G/4G). Communication devices can be cellphones, computers or other dedicated communication modems.
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