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510(k) Data Aggregation
K Number
K213038Device Name
Infrared Forehead Thermometer, model: HS-9802D
Date Cleared
2022-03-10
(170 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Jiaxing Shangjia Intelligence Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Infrared Forehead Thermometer, model: HS-9802D is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.
Device Description
Infrared Forehead Thermometer, model: HS-9802D is a hand-held, battery powered, infrared thermometer that measures human body temperature from forehead. The reference body site is oral. The device measures temperature from center of the forehead.
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