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510(k) Data Aggregation

    K Number
    K113054
    Device Name
    EQUIVITAL
    Manufacturer
    HIDALGO LIMITED
    Date Cleared
    2012-02-17

    (127 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    HIDALGO LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Equivital™ Vital Signs Physiological Monitor is an ambulatory multiparameter vital signs telemetry device intended for monitoring of adults (16 - 65years) in hospital in the mital in the mater vital care facilities, the home, workplace for monitoning of addits (11) facilities, the home, workplace and alternate care settings. The device consists of a chest belt harness and a body worn electronics module (SEM) supported by the chest belt. The device collects and transmits ECG data and rate, respiration data and rate, skin temperature, body orientation and motion temperature, body orientation and motion. The monitor is indicated for use as a general patient monitor, to provide physiological information as part of an occupational welfare monitor, to provide physiology research and performance measuroment purpos research and performance measurement purposes.
    Device Description
    The Equivital™ Vital Signs Physiological Monitor comprises two components: i) A chest belt containing skin electrodes and an expansion sensor ii) A battery powered electronics module which connects directly to the chest belt and which acts to record, digitise and transmit the physiological information wirelessly to a receiving display device. The device offers continuous monitoring of two views of the user's heart electrical activity (ECG) and respiratory breathing frequency inferred from thoracic cavity movement and uses this data to derive a Heart Rate and a Breathing Effort Rate. The sensor also provides the following information: - ECG and Respiration physiological waveforms . - An indication of the user's activity level derived from a movement detection sensor . - Body orientation and indications for change in orientation . - Skin surface temperature . - Alternate secondary measurement of heart rate based on the detection of the user's R . wave using a separate hardware processing function - . Indications and alerts if physiology exceeds predefined boundaries - Alternate secondary skin temperature measurement using infrared thermometer . The device offers two variants for the wireless interface: a low power radio interface and a general purpose interface using Bluetooth™ technology. The device offers two battery power options for the user, rechargeable or primary disposable cells. The wireless data provided by the sensor may be viewed using a standalone PC based viewing application, or integrated into third party monitoring applications.
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    K Number
    K061993
    Device Name
    EQUIVITAL, MODEL EQ-01
    Manufacturer
    HIDALGO LIMITED
    Date Cleared
    2006-11-03

    (112 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    HIDALGO LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Equivital™ Vital Signs Physiological Monitor is an ambulatory multiparameter vital signs telemetry device intended for monitoring of adults (16 - 65years) in hospital care facilities, the home, workplace, and alternate care settings. The device consists of a chest belt harness and a body worn electronics module (SEM) supported by the chest belt). The device collects and transmits ECG data and rate, respiration data and rate, skin temperature, body orientation and motion. The monitor is indicated for use as a general patient monitor, to provide physiological information as part of an occupational welfare monitoring system, and for general research and performance measurement purposes.
    Device Description
    The Equivital™ Vital Signs Physiological Monitor comprises two components: i) A chest belt containing skin electrodes and an expansion sensor ii) A battery powered electronics module which connects directly to the chest belt and which acts to record, digitise and transmit the physiological information wirelessly to a receiving display device. The device offers continuous monitoring of two views of the user's heart electrical activity (ECG) and respiratory breathing frequency inferred from thoracic cavity movement and uses this data to derive a Heart Rate and a Breathing Effort Rate. The sensor also provides the following information: - ECG and Respiration physiological waveforms. . - an indication of the user's activity level (none, low or high) derived from a movement . detection sensor. - . Body orientation. - Chest skin surface temperature. . - alternate secondary measurement of heart rate based on the detection of the user's R . wave using a separate hardware processing function. - indications and alerts if physiology exceeds predefined boundaries. . The device offers two variants for the wireless interface: a low power radio interface designed for military applications and a general purpose interface using Bluetooth™ technology. The device offers two battery power options for the user, rechargeable or primary disposable cells. The wireless data provided by the sensor may be viewed using a standalone PC based viewing application, or integrated into third party monitoring applications.
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