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510(k) Data Aggregation
K Number
K221800Device Name
Infrared Thermometer (Model: Y20001, Y20002)
Date Cleared
2022-12-14
(176 days)
Product Code
Regulation Number
880.2910Why 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
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K Number
K213023Device Name
Blood Pressure Monitor(Model:Y30001)
Date Cleared
2022-09-30
(374 days)
Product Code
Regulation Number
870.1130Why 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
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