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510(k) Data Aggregation

    K Number
    K200434
    Device Name
    V20, V20a, AVSM3 SNF
    Manufacturer
    Mediana Co., Ltd.
    Date Cleared
    2020-10-09

    (228 days)

    Product Code
    DXN, DQA, FLL
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mediana Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR) and temperature (TEMP) in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V20 and V20a are for adult, pediatric and neonatal patients and the AVSM3 SNF is for adult patients only. Also, the V20 is only suitable for single measurement but V20a and AVSM3 SNF are suitable for single as well as continuous measurement.
    Device Description
    The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR) and temperature (TEMP) in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V20 and V20a are for adult, pediatric and neonatal patients and the AVSM3 SNF is for adult patients only. Also, the V20 is only suitable for single measurement but V20a and AVSM3 SNF are suitable for single as well as continuous measurement. The Mediana V20, V20a, AVSM3 SNF vital signs monitors are a lightweight and compact device (249 x 211 x 176 (mm) (W×H×D) and 3.1 kg for Standard configuration) powered by AC mains (100-240VAC, 50Hz/60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 8″ TFT-LCD screen.
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    K Number
    K170497
    Device Name
    V10
    Manufacturer
    Mediana Co., Ltd.
    Date Cleared
    2017-12-15

    (301 days)

    Product Code
    DXN, DQA, FLL
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mediana Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V10 is suitable for continuous operation.
    Device Description
    The V10 vital signs monitor non-invasive blood pressure, pulse rate, non-invasive functional oxygen saturation of arterial hemoglobin for adult, pediatric and neonate patients and body temperature for adult and pediatric patients in general hospital and alternate care facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional. The Mediana V10 vital signs monitor is a lightweight and compact device (249 x 211 x 154 (mm) (WxHxD) and 3.0 kg) powered by AC mains (100-240VAC, 50Hz/60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 7-segment LED displays.
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    K Number
    K160358
    Device Name
    DT-100
    Manufacturer
    Mediana Co., Ltd.
    Date Cleared
    2017-02-24

    (381 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mediana Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DT-100 non-contact infrared thermometer is intended to be used to measure the body temperature using infrared sensors. It can detect the body temperature of all ages from human's face. The DT-100 infrared thermometer can be used by consumers in household environment.
    Device Description
    The DT-100 non-contact infrared thermometer is intended to be used to measure the body temperature using infrared sensors. It can detect the body temperature of all ages from human's face. The operation principle is based on infrared sensor technology. IR sensor can put out different signal when measuring the different object temperature or body temperature. An ASIC can turn the signal from IR sensor to a digital value and display it by LCD. The DT-100 noncontact infrared thermometer can measure body temperature at maximum 40cm between patient and product. The thermometer stores temperature measurement value up to 30, a user can compare prior measurement value and uses an alkaline battery AAA type for operation.
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    K Number
    K112190
    Device Name
    PATIENT MONITOR
    Manufacturer
    MEDIANA CO., LTD.
    Date Cleared
    2011-11-09

    (103 days)

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

    MEDIANA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The YM6000 monitor is intended to be used to monitor electrocardiography, heart rate, pulse rate, noninvasive blood pressure (systolic, diastolic and mean arterial pressures), functional arterial oxygen saturation, invasive blood pressure, respiration, capnography (EtCO2 and InCO2) and temperature for adult, pediatric a nd neonate patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist.
    Device Description
    The YM6000 patient monitor is to monitor electrocardiography (ECG), Arrhythmia, ST segment, heart rate (HR), pulse rate, noninyasive blood pressure (systolic, diastolic and mean arterial pressures); functional arterial oxyge n saturation, invasive b lood pressure, respiration, capnography (EtCO2 and InCO2) and temperature for adult, pediatric and neonate in patients in general hospital and alternate ca re facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional. The YM6000 patient monitor is a lightweight and compact device (341 × 305 × 172 (mm) (W × H × D) and 5.5 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on TFT-LCD displays.
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    K Number
    K110612
    Device Name
    FM20
    Manufacturer
    MEDIANA CO., LTD.
    Date Cleared
    2011-11-08

    (250 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIANA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FM20 is a Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel LCD(7") Display, recorded on a strip chart recorder and may be transmitted over RS232 port to a remote data receiver. Single/Twin fetal heart rates may be measured by means of Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer. The FM20 is intended to be used during the antepartum periods on pregnant woman.
    Device Description
    FM20 is the fetal monitor that measures uterine contractions and fetal heart rate (FHR) which may be used to predict fetal status. To detect the Doppler frequency signal reflected from the heart of the fetus, FM20 irradiates ultrasound wave to the abdomen of a pregnant woman. FM20 analyzes this signal and displays the heart rate by LCD. Also, FM20 provides the sound from the heart of fetus. FM20 measures the uterine contraction of a pregnant woman by pressure sensors and displays the numerical values. And FM20 prints the heart rate of the fetus and the values of uterine contraction. FM20 records the heart rate of the fetus, the uterine contraction of a pregnant woman. and basic information of the equipment with a provided thermal orinter. FM20 is capable of Twin Monitoring with two pulsed Ultrasound Transducers. FM20 has a free voltage(100 - 240VAC input) power adaptor. FM20 has Fetal movement detection function. To extract fetal movement signal, FM20 uses a circuit and digital filter. FM20 has Event marker function so that the patient can record the time of important events. FM20 has the capability to alert the caregiver in the event a heart rate goes above or below limit for a preset time delay.
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    K Number
    K110630
    Device Name
    F10
    Manufacturer
    MEDIANA CO., LTD.
    Date Cleared
    2011-06-24

    (113 days)

    Product Code
    KNG
    Regulation Number
    884.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIANA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The F10 Fetal Doppler measures heart rate, which is displayed on a LCD display and provides fetal heart sounds. The fetal heart rate is measured using Doppler ultrasound.
    Device Description
    F10 is a pocket-size fetal Doppler that measures the fetal heat rate and outputs the fetal heart sound through built-in speaker. By measuring fetal heart rate(FHR), you are able to predict fetal well-being. F10 irradiates fetal wave to the abdomen of a pregnant woman to detect the Doppler frequency signal and analyze, and displays the heart rate on LCD screen. The device also provides the heart sound from the heart of fetus
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    K Number
    K100225
    Device Name
    PULSE OXIMETER MODEL P10
    Manufacturer
    MEDIANA CO., LTD.
    Date Cleared
    2011-02-09

    (379 days)

    Product Code
    DQA, P10, PUL
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIANA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The P10 pulse oximeter is intended to be used to monitor functional arterial oxygen saturation (SpO2) and pulse rate in all areas of a hospital, hospital, hospital-type facilities, intra-hospital transport and home environments. Users should be skilled at the level of a technician, doctor, nurse or medical specialist. Note: The continuous monitoring and Spot check mode are user-selectable. The mode of operation is the continuous monitoring except when the Spot Check Mode (03) is enabled.
    Device Description
    The P10 Pulse Oximter is to monitor non-invasive functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate for adult, pediatric and neonate patients in general hospital and alternate care facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional. The Mediana P10 Pulse Oximeter is a lightweight and compact device (58×105×21mm and 90g) powered by 3 Alkaline AAA batteries. The monitor provides patient data and monitoring status on LCD displays. MD1 module is used for SpO2 module, and YM-1 reusable sensor is used for SpO2 sensor.
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    K Number
    K100217
    Device Name
    LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30
    Manufacturer
    MEDIANA CO., LTD.
    Date Cleared
    2010-06-08

    (134 days)

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

    MEDIANA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lucon M-series (M20, M30) is intended to be used to monitor for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician. The device is capable of monitoring: - Electrocardiography (ECG) - Heart rate (HR) - Noninvasive blood pressure (NIBP) - Functional arterial oxygen saturation (SpO2) - Pulse rate (PR) - Respiration rate (RR) - Temperature (Temp) - Arrhythmia/ST segment (M30 only) - Capnography (M30 only) Note: Hospital use typically includes such areas as general care floors, operating rooms, special procedure areas, intensive and critical care area, within the hospital. Hospital type facilities include physician office-based facilities, sleep labs, skilled nursing facilities, surgical centers, and sub acute care centers. Note: The medically skilled and trained user can be clinicians like doctors and nurses who know to take and interpret a patient's vital signs. These clinicians must take direct responsibility for the patient's life. This can include care-givers or medically trained interpreters who are authorized under the appropriate clinical facility procedures to support patient care. Any inappropriate setting, especially the alarm limit or alarm notification settings, can lead to a hazardous situation that injures the patient, harms the patient, or threatens the patient's life. This equipment should only be operated by trained users who can adjust the settings of the patient monitor.
    Device Description
    The Mediana Lucon M-series (M20, M30) patient monitor is a lightweight and compact device (250 × 210 × 170 (mm) and 3.2 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on TFT-LCD displays. - Electrocardiography (ECG) - Heart rate (HR) - Noninvasive blood pressure (NIBP) - Functional arterial oxygen saturation (SpO2) - Pulse rate (PR) - Respiration rate (RR) - Temperature (Temp) - Arrhythmia/ST segment (M30 only) - Capnography (M30 only)
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    K Number
    K051375
    Device Name
    VITAL SIGNS MONITOR
    Manufacturer
    MEDIANA CO., LTD.
    Date Cleared
    2005-07-28

    (63 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIANA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The purpose and function of the Mediana ARGUS VCM vital signs monitor is to monitor non-invasive blood pressure (systolic, diastolic, and mean arterial pressures), functional arterial oxygen saturation, pulse rate for adult, pediatric and neonate patients and temperature for adult and pediatric patients in all hospital areas and hospital-type facilities. It may be used during hospital transport and in mobile, land-based environments, such as ambulances, within the specification of the environmental characteristics. - Note: Hospital use typically covers such areas as general care floors, operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities. Hospital-type facilities include physician office based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acutecenters. - Note: Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility.
    Device Description
    The ARGUS VCM vital signs monitor is to monitor non-invasive blood pressure, pulse rate, non-invasive functional oxygen saturation of arterial hemoglobin (SpO2) for adult, pediatric and neonate patients and body temperature for adult and pediatric patients in general hospital and alternate care facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional. The Mediana ARGUS VCM vital signs monitor is a lightweight and compact device (180×278×130 mm and 2.7 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 7segment and LED displays.
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