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510(k) Data Aggregation

    K Number
    K113183
    Device Name
    PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500
    Date Cleared
    2012-02-09

    (104 days)

    Product Code
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI 3F ELECTRONICS CO LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PMS8210A Model Code 500 is a multi-parameters monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PMS8210A Model Code 500 has certain features and functions. The patient parameters that can be monitored by PMS8210A Model Code 500 are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Arterial Hemoglobin Oxygen Saturation(SpO2), Temperature (TEMP) and End-tidal CO2 (EtCO2) . Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs. The PMS8210A Model Code 500 is intended for use in a health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment. The PMS8210A Model Code 500 is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician.
    Device Description
    PMS8210A Model Code 500 Patient Monitor is a battery or line-powered patient monitor. The Patient Monitor acquires the physiological signals such as ECG, respiration (RESP), Non-Invasive blood pressure (NIBP), Saturation of pulse oxygen (SPO2), Temperature (TEMP), End-tidal (etCO₂). The signals are converted into digital data and processed, examines the data for alarm conditions and displays the data. The monitor also provides operating control for the user. The submitted device is the same as the predicate with two differences. The new model has added an etCO2 function and the Temp module has been changed. The new Temp module is a previously FDA cleared device.
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    K Number
    K100394
    Device Name
    MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A
    Date Cleared
    2010-04-15

    (58 days)

    Product Code
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANGHAI 3F ELECTRONICS CO LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PMS8210A Multi Parameter Patient Monitor is a multi-parameters monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PMS8210A Patient Monitor has certain features and functions. The patient parameters that can be monitored by PMS8210A Patient Monitor are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Arterial Hemoglobin Oxygen Saturation(SpO2) and Temperature (TEMP). Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs. The PMS8210A Patient Monitor is intended for use in a health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment. The PMS8210A Patient Monitor is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician.
    Device Description
    PMS8210A Patient Monitor is a battery or line-powered patient monitor. The Patient Monitor acquires the physiological signals such as ECG, respiration (RESP), Non-Invasive blood pressure (NIBP), Saturation of pulse oxygen (SPO2), Temperature (TEMP), Heart rate (HR) and Pulse Rate (PR), The signals are converted into digital data and processed, examines the data for alarm conditions and displays the data. The monitor also provides operating control for the user.
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