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510(k) Data Aggregation
K Number
K203497Device Name
Infrared Thermometer (Model K9)
Manufacturer
Date Cleared
2021-10-08
(315 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Kangzhan Communication Electronics Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Infrared Thermometer, Model K9 is a non-contact intended for the intermittent measurement and monitoring of human body temperature from forehead for clinical and home use environments. It can be used for anybody, e.g. for infant, children and adults (Excluding neonates). The device does not require sterilization and can be reused.
Device Description
The Infrared Thermometer. Model K9 is an electronic thermometer using an infrared sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to a temperature value. The device uses CapSense Technology to detect distance this technology is used to assist measurement. The concept of proximity sensor detects human electrical proximity level to transform to distance. The distance control feature is added to the user interface to identify the measurement distances are in the correct parameter. In other words, the device will enter into measurement mode after the correct measurement distance is detected. This device can take a measurement automatically when the device detects the distance is appropriate within 5 cm. The Infrared Thermometer, Model K9, consists of the following parts: a) Thermopile Sensor b) Application-Specific Integrated Circuitry c) Erasable Programmable Read-Only Memory Integrated Circuit d) Capacitance-touch Integrated Circuit e) LED and Backlight f) Alkaline batteries; size AAA, 2 x 1.5 V g) Lens
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