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510(k) Data Aggregation

    K Number
    K193456
    Device Name
    Arm Blood Pressure Monitor
    Manufacturer
    Ningbo Ranor Medical Science & Technology Co., Ltd.
    Date Cleared
    2020-07-16

    (216 days)

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

    **Ningbo Ranor Medical Science **& Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arm blood pressure monitor is for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy.
    Device Description
    The proposed device, Arm Blood Pressure Monitor, is an automatic noninvasive Blood Pressure Monitor which can be driven by dry batteries. It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult, not for neonate or pregnancy. The proposed device consists of the main body and the arm belt, suitable for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy. This blood pressure monitor has the memory function of 60 groups of measuring data of two people, which can save the data separately. It can display the average reading of the latest 3 groups of measurement results. This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not according to the World Health Organization/ International Society for hypertension(WHO/ISH) guidelines on the treatment of hypertension dated in 1999. This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips. Cuff supporting the use of Arm Blood Pressure Monitor is M5303(small adult)/M5304(adult)/ M5305(big adult) provided by Xuzhou Maikang Science and Technology Ltd., and cleared by the CE(Declaration of Conformity for Class I)/ISO and FDA(K151290).
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    K Number
    K200578
    Device Name
    Infrared Thermometer Model Number RN-50A,RN-50B
    Manufacturer
    Ningbo Ranor Medical Science & Technology Co., Ltd.
    Date Cleared
    2020-07-16

    (133 days)

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

    **Ningbo Ranor Medical Science **& Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of one month old and above. The device is reusable for home use and clinical use.
    Device Description
    The Infrared Thermometer, Models RN-50A and RN-50B are hand-held device powered by 2*AA batteries and designed to measure human body temperature without contacting patient' forehead. The Infrared Thermometers RN-50A and RN-50B measure the temperature by using the principle of receiving infrared. An object with a temperature higher than absolute zero will radiate a certain amount of infrared energy. According to the infrared energy and wavelength, the surface temperature of the object can be determined. The temperature of human forehead is relatively constant, so the temperature of human forehead can be measured according to this principle. The thermometer adopts a new CMOS compatible thermopile sensor with good sensitivity. The pressure difference generated by the sensor after receiving the infrared signal is amplified and analyzed then display on the LCD screen in digital form. The measurement distance of the subject device is 3~5 cm from the forehead. The only differences among the RN-50A and RN-50B thermometers are size, weight, shape of enclosure.
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    K Number
    K200471
    Device Name
    Infrared Thermometer Model Number RN-60A,RN-60B
    Manufacturer
    Ningbo Ranor Medical Science & Technology Co., Ltd.
    Date Cleared
    2020-06-19

    (114 days)

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

    **Ningbo Ranor Medical Science **& Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of one month old and above. The device is reusable for home use and clinical use.
    Device Description
    The Infrared Thermometer, Models RN-60A and RN-60B are hand-held device powered by 2*AAA batteries and designed to measure human body temperature without contacting patient' forehead. The Infrared Thermometers RN-60A and RN-60B measure the temperature by using the principle of receiving infrared. An object with a temperature higher than absolute zero will radiate a certain amount of infrared energy. According to the infrared energy and wavelength, the surface temperature of the object can be determined. The temperature of human forehead is relatively constant, so the temperature of human forehead can be measured according to this principle. The thermometer adopts a new CMOS compatible thermopile sensor with good sensitivity. The pressure difference generated by the sensor after receiving the infrared signal is amplified and analyzed then display on the LCD screen in digital form. The measurement distance of the subject device is 3~5 cm from the forehead. The only differences among the RN-60A and RN-60B thermometers are size, weight, shape of enclosure.
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