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510(k) Data Aggregation

    K Number
    K142244
    Device Name
    CLEO PATIENT MONITOR
    Manufacturer
    Date Cleared
    2015-02-06

    (177 days)

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

    INFINIUM MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The purpose and function of the CLEO patient monitor is to monitor basic physiological parameters including - NIBP (systolic and diastolic) - SpO2 - ETCO2 The target population is for adults only. It can be used in all hospital areas and hospital-type facilities. It may be used as bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
    Device Description
    The CLEO monitor is a comprehensive monitoring system with two or three traces compiling, and processing, analyzing and displaying data from up to three different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient. The CLEO Patient monitor can be powered by an internal battery pack that provides 3 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor. The associated accessories include: - Sp02 Finger Sensors - NIBP Monitor - Blood Pressure Cuff - ETCO2 Module
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    K Number
    K132229
    Device Name
    OMNI PATENT MONITORS
    Manufacturer
    Date Cleared
    2014-02-21

    (218 days)

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

    INFINIUM MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The purpose and function of the OMNI patient monitor is to monitor basic physiological parameters including - ECG waveform derived from 3, 5 or 12 lead measurements . - Heart Rate . - NIBP(systolic, diastolic, and mean arterial pressure) . - . SpO2 - Respiration . - Temperature up to 2 channels (Dual Temperature) . - . CO2 - IBP . - Anesthetic agents . The target population is for adult, neonate and pediatric patients. It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner. The purpose and function of the OMNI II patient monitor is to monitor basic physiological parameters including - ECG waveform derived from 3, 5 or 12 lead measurements . - Heart Rate . - NIBP(systolic, diastolic, and mean arterial pressure) . - SpO2 . - Respiration . - Temperature up to 2 channels (Dual Temperature) . - . CO2 - . Cardiac Output - IBP . - . Anesthetic agents The target population is for adult, neonate and pediatric patients with the exception of: - · Cardiac Output for which the target population is adult only. It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner. The purpose and function of the OMNI III patient monitor is to monitor basic physiological parameters including - ECG waveform derived from 3, 5 or 12 lead measurements . - Heart Rate . - NIBP(systolic, diastolic, and mean arterial pressure) . - SpO2 . - Respiration . - Temperature up to 2 channels (Dual Temperature) . - CO2 . - Cardiac Output ● - . IBP - Anesthetic agents . The target population is for adult, neonate and pediatric patients with the exception of: - · Cardiac Output for which the target population is adult only. It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner. The purpose and function of the OMNI Express patient monitor is to monitor basic physiological parameters including - ECG waveform derived from 3 to 5 lead measurements . - Heart Rate . - NIBP(systolic, diastolic, and mean arterial pressure) ● - . SpO2 - . Respiration - . Temperature - up to 2 channels (Dual Temperature) - CO2 - . Anesthetic agents The target population is for adult, neonate and pediatric patients. It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.
    Device Description
    The OMNI monitor is a comprehensive monitoring system with four, six or eight traces compiling, and processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient. The OMNI monitor can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor. The OMNI II monitor is a comprehensive monitoring system with four, six or eight traces compiling, and processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient. The OMNI II monitor can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor. The OMNI III monitor is a comprehensive monitoring system with eight traces compiling, and processing, analyzing and displaying data from up to six different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability, Built-in battery facilitates transportation of patient. The OMNI III can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor. The OMNI EXPRESS monitor is a comprehensive monitoring system with two or three traces compiling, and processing, analyzing and displaying data from up to eight different patient parameters, It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient. The OMNI EXPRESS monitor can be powered by an internal battery pack that provides 2 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.
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    K Number
    K112329
    Device Name
    OMNI PATIENT MONITOR
    Manufacturer
    Date Cleared
    2011-09-08

    (27 days)

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

    INFINIUM MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The purpose and function of the OMNI Patient monitor is to monitor ECG, heart rate, NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature, for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities.
    Device Description
    The OMNI patient monitor is a comprehensive monitoring system with three or six traces compiling, processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient. The OMNI patient monitor can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.
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    K Number
    K103737
    Device Name
    OMNI II PATIENT MONITOR
    Manufacturer
    Date Cleared
    2011-06-02

    (162 days)

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

    INFINIUM MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The purpose and function of the OMNI II Patient monitor is to monitor ECG, heart rate, NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature, for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals and hospital type facilities such as clinics and emergency room facilities.
    Device Description
    The OMNI II monitor is a comprehensive monitoring system with four, six or eight traces compiling, processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient. The OMNI II monitor can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.
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    K Number
    K103268
    Device Name
    OMNI EXPRESS
    Manufacturer
    Date Cleared
    2010-11-23

    (19 days)

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

    INFINIUM MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The purpose and function of the Omni Express patient monitor is to monitor basic physiological parameters including, ECG, heart rate. NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals anf hospital-type facilities such as clinics and emergency room facilities.
    Device Description
    The OMNI Express patient monitor is a comprehensive monitoring system with two or three traces compiling, processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient. The OMNI Express monitor can be powered by an internal battery pack that provides 3 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.
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    K Number
    K101052
    Device Name
    OMNI III PATIENT MONITOR
    Manufacturer
    Date Cleared
    2010-08-11

    (118 days)

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

    INFINIUM MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The purpose and function of the OMNI III patient monitor is to monitor basic physiological parameters including, ECG, heart rate, NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities.
    Device Description
    The OMNI III monitor is a comprehensive monitoring system with eight traces compiling, processing, analyzing and displaying data from up to six different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.
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