Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K221800
    Device Name
    Infrared Thermometer (Model: Y20001, Y20002)
    Date Cleared
    2022-12-14

    (176 days)

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

    Zhangzhou Easepal Medical Science And Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Infrared Thermometer (Model: Y2001, Y20002) is intended for the intermittent measurement and monitoring of human body temperature from forehead. The device is indicated for use for people of two months and above at homecare and in hospital.
    Device Description
    Infrared thermometer (Model: Y20001 , Y20002) are a hand-held, battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead when measure from 1-3cm of the subject's forehead with no contact. The temperature will displayed on the screen, and the reference body site is axilla. Infrared thermometer (Model: Y20001, Y20002) use a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the thermometer for ambient temperature readings. The device consists of measuring sensor, PCB, buttons, a LCD and an enclosure. The difference between two models are size, weight and button settings. Y20001 has four buttons(Test button, °C/°F button, "B/S"button, "M" key) and Y20002 has two buttons(Function button, Measurement button). The functions of the two models are same. Infrared thermometer (Model: Y20001,Y20002) have the following features: 1) The device is intended to be reusable for home use and clinical use. 2) Switching of temperature unit between °C and °F. 3) The latest 32 sets of memory for measuring human body and object; the user can view or delete the previous measurement results. 4) Buzzer on or off to set the prompt tone on or off. 5) Prompt tone function. 6) Low battery indication, and auto power-off
    Ask a Question

    Ask a specific question about this device

    K Number
    K213023
    Device Name
    Blood Pressure Monitor(Model:Y30001)
    Date Cleared
    2022-09-30

    (374 days)

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

    Zhangzhou Easepal Medical Science And Technology Co.,LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1