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510(k) Data Aggregation

    K Number
    K152973
    Device Name
    Dyna-Vision Telemonitoring System
    Date Cleared
    2016-04-29

    (204 days)

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

    Techmedic Development International B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dyna-Vision Telemontoring System is a wreless monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings and for normal daily activities. Physiological data recorded include: Electrocardiography (EGG), Heart Rate variability (R-R interval), Peripheral capillary Oxygen saturation (SpO2), Skin Temperature and respiration effort Data is transmitted wirelessly in near real time to a central location where it is stored for analysis. The Dyna-Vision™ system can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters. Data from the Dyna-Vision™ system is intended to be used by healthcare professionals as an aid to diagnosis and treatment. The device is intended for use on general care patients aged 18 years or more, as a general patient monitor, to provide physiological information. It is not intended for use on critical care patients.
    Device Description
    The Dyna-Vision system is a wireless multi-parameter data collection systems that monitors physiological data such as: Electrocardiography (EGG), Heart Rate, Heart Rate variability (R-R interval), Peripheral capillary Oxygen saturation (SpO2), Skin Temperature and Rate of respiratory effort. The system consist of: • A body-worn unit with sensor input modules for the near real time acquisition of the physiological data with built-in wireless communication for data transmission. • A telemetry server to receive the physiological data and transmit the physiological data to • A workstation installed on a central server (or PC) equipped with software with which the physician can process the physiological data and create reports regarding the transmitted data, and read and configure alerts/notifications when a threshold value is exceeded. The alert function is an adjunct to and not intended to replace vital sign monitoring. The software includes algorithms for Heart Rate, Heart Rate variability (R-R interval) and rate of respiratory effort. The device is intended to be used by clinicians and medically qualified personnel in healthcare facilities. The body-worn unit for data acquisition, is a transportable battery-operated unit to record Electrocardiograph (ECG), Heart Rate variability (R-R interval), Peripheral capillary Oxygen saturation (SpO2), Skin Temperature and Rate of respiratory effort to be also used by the patient in the home setting and anywhere where WIFI or cell communication is available. The Dyna-Vision system works with 3rd party 510(k) cleared SpO2 module (Nonin OEM III, K092101), and ECG patient lead (Scottcare K092947). The device is intended for use on general care patients aged 18 years or more.
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