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510(k) Data Aggregation

    K Number
    K123797
    Device Name
    NT1D VITAL SIGNS MONITOR
    Manufacturer
    Date Cleared
    2013-08-27

    (260 days)

    Product Code
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEW TECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NTID is a handheld vital signs monitor that continuously monitors end tidal carbon dioxide (EtCO2), respiratory rate (RR), oxygen saturation (SpO2), and pulse rate. The unit is intended for monitoring only . The unit transfers history data to PC through a USB adapter. It is for use in any environment where continuous, noninvasive monitoring of these parameters is desired, including hospital and hospital-type facilities. The monitor is intended for use on adult and pediatric patients.
    Device Description
    NTID Vital Signs Monitor provides: * SpO2 monitoring * Pulse rate (PR) monitoring * End tidal carbon dioxide (EtCO2) monitoring * Respiration rate (RR) monitoring * CO2 and SpO2 waveform display * Audible and visual physiological and technical alarms * Trend graph and trend table review * Alarm event records review * History data storage * Rechargeable batteries * External power supply and charger The monitor is intended for monitoring adult and pediatric patients in clinical environments where healthcare is provided by healthcare professionals. The product is composed of monitor, SpO2 sensor, Mainstream/Sidestream CO2 sensor, charging base, USB Adapter and PC software.
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