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510(k) Data Aggregation
K Number
K163603Device Name
Digital Thermometer
Manufacturer
Guangzhou Jinxinbao Electronic Co., Ltd
Date Cleared
2017-06-06
(167 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Jinxinbao Electronic Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Digital Thermometer is intended to measure the body temperature either oral or axillaries (under arms) and to be used by consumers in a household environment. The device is intended for repeatable use by one patient. It is intended for use on people of all ages.
Device Description
The Digital Thermometer utilizes measured thermistor resistance and a microcontroller unit to determine and display human body temperature. Changes in the probe temperature due to oral or auxiliary contact correspond to changes in resistance. The probe Temperature values are digitally displayed on an LCD screen in 0.2 degrees Fahrenheit increments. The measurements do not account for a probe cover. The user contacting materials are Stainless steel and Acrylonitrile Butadiene Styrene (ABS).
The Digital Thermometer includes 3 models: DT001, DT007 and DT008. The differences of these models are in appearance and specifications. All of them have the same basic functions:
- Precision of 0.1℃ for measurements between 35℃ and 39℃ for measurement
- Data displayed in Celsius -
- Automatic stop (energy saver) -
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