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510(k) Data Aggregation
K Number
K230889Device Name
Digital Thermometer
Manufacturer
Date Cleared
2024-04-03
(369 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Wenzhou Yosun Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Digital Thermometer is intended to measure body temperature orally, rectally and under the arm (armpit). The devices are reusable in a clinical or home use setting on people of all ages, including children under the age of 8 with adult supervision.
Device Description
Digital Thermometer
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K Number
K201843Device Name
Infrared ear and forehead thermometer, model YI-100
Manufacturer
Date Cleared
2020-10-23
(109 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Wenzhou Yosun Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Infrared ear and forehead thermometer model YI-100 is a multi-function infrared thermometer intended for the intermittent measurement of human body temperature by Ear mode, or by Forehead mode (moving the mead from one temple to another temple for forehead measurement). The device can be used on people of one month old and above.
Device Description
Infrared ear and forehead thermometer, model: YI-100
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