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510(k) Data Aggregation

    K Number
    K092970
    Device Name
    GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H
    Date Cleared
    2010-02-02

    (130 days)

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

    GENERAL MEDITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    General Patient Monitors is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (BP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance.
    Device Description
    The proposed device, M Series Patient Monitor (M66, M69, M8000 and M9000) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters. It has the physical and technical alarming function with audio and visual alarming, The device can driven by AC or DC power supply.
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    K Number
    K082789
    Device Name
    G1B PULSE OXIMETER
    Date Cleared
    2009-01-07

    (106 days)

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

    GENERAL MEDITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    G1B Pulse Oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatic patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care and etc). Not for continuously monitoring,
    Device Description
    The G1B is a flexible, portable, battery powered Pulse Oximeter. The G1B Pulse Oximeter acquires the physiological signals - oxygen saturation (SpO2) and pulse rate (PR). The signals are converted into digital data and processed, and the SpO2 and pulse rate values are calculated and displayed on LED screen. G1B uses a two-wavelength pulsatile system - red and infrared light - to obtain SpO2 based on the different light absorption of oxygenated and reduced hemoglobin. The light source in the finger sensor emits red and infrared light, which are partially absorbed and modulated by the arterial blood pulsation at the sensor site. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The electronic signals are sent to the oximeter and processed by the oximeter's circuitry. Thereafter, the SpO2 and pulse rate are obtained and indicated on the LED screen.
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