Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K202420
    Device Name
    Infrared Forehead Thermometer
    Manufacturer
    Conmo Electronic Company Limited
    Date Cleared
    2021-02-25

    (185 days)

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

    Conmo Electronic Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The infrared forehead Thermometer DPT-IFT100 is a non-contact 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 forehead thermometer, Model DPT-IFT100, is an electronic thermometer using an infrared temperature sensor to measure infrared energy radiated from the forehead. This energy is collected through the infrared temperature sensor convert to a voltage signal. The signal is measured by the main microcontroller, calculated by the internal algorithm, finally converted into a digital temperature value to display on the LCD. The design consists of a lens to focus the infrared thermal radiation on to a detector, which converts the radiant power to an electrical signal displayed in units of temperature after being compensated for ambient temperature. This permits temperature measurement from a 3~5 cm distance without contact with the object to be measured. The Infrared forehead thermometer, Model DPT-IFT100, consists of the following parts: a) Thermopile Sensor b) Application-Specific Integrated Circuit c) Housing d) LCD and Backlight e) 1 button (Power on/Power off/Measurement) f) Alkaline batteries; size AAA, 2 x 1.5 V g) LCD cover
    Ask a Question
    K Number
    K202372
    Device Name
    Upper Arm Electronic Blood Pressure Monitor
    Manufacturer
    Conmo Electronic Company Limited
    Date Cleared
    2020-12-30

    (133 days)

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

    Conmo Electronic Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Upper Arm Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia).
    Device Description
    The Upper Arm Electronic Blood Pressure Monitor, Model BM100-EN operation is based on the oscillometric method. This method takes advantage of the pressure pulsations taken during measurements. An occluding cuff is placed on the left arm and is connected to an air pump and a pressure sensor. The cuff is inflated until a pressure higher than the typical systolic value is reached, then the cuff is slowly deflated. As the cuff deflates, when systolic pressure value approaches, pulsations start to appear. These pulsations represent the pressure changes due to heart ventricle contraction and can be used to calculate the heartbeat rate. Pulsations grow in amplitude until mean arterial pressure (MAP) is reached, then decrease until they disappear. The blood pressure information is displayed as digital information on the device's screen.
    Ask a Question
    K Number
    K140594
    Device Name
    BODY FAT ANALYZER AND SCALE
    Manufacturer
    CONMO ELECTRONIC COMPANY LIMITED
    Date Cleared
    2014-05-30

    (84 days)

    Product Code
    MNW
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONMO ELECTRONIC COMPANY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Body Fat Analyzer and Scale measures body weight and impedance and estimates percentage of body fat, body water and body muscle mass using BIA (bioelectrical impedance analysis). It is intended for use by healthy adults 18 years of age or older who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy for body composition assessment in the home environment.
    Device Description
    The patient steps on the scale device, where four electrodes are located. The patient must step on the electrodes with bare feet, with normal moisture. Through harmless current stimulation of 500 µA, at 50 kHz, the Conmo Electronic Company Limited Body Fat Analyzer and Scale provides weight, calculates the body fat, body water and body muscle mass. This calculation is done via the Bioelectrical Impedance Method. The current is passed through the body and the impedance of the body determines the body fat. The calculation is based upon electrical impedance, height, weight, age, and gender. The calculation is performed via internal software, which uses the variables programmed in by the user. There are elements of this process that can produce erroneous readings, such as dry feet or improper-programmed data. The User's Manual defines items which could cause erroneous readings.
    Ask a Question

    Page 1 of 1