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510(k) Data Aggregation
K Number
K152640Device Name
Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)
Manufacturer
FUDAKANG INDUSTRIES CO., LTD
Date Cleared
2016-03-28
(195 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
FUDAKANG INDUSTRIES CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Infrared Thermometer (FT-F11-BT) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.
Infrared Thermometers (FT-F21-BT, FT-F41-BT) are intended for intermittent measurement of human body temperature in people of all ages.
Device Description
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K Number
K101387Device Name
DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN
Manufacturer
FUDAKANG INDUSTRIES CO., LTD
Date Cleared
2010-08-03
(77 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
FUDAKANG INDUSTRIES CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fudakang Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home. BT-A11CN, BT-A21CN, BT-A41CN can be used for axillary measurement, oral measurement and rectal measurement.
Device Description
Fudakang digital thermometers are hand-held, reusable, battery operated. The models include BT-A11CN, BT-A21CN, and BT-A41CN. All the models have the same indication for use. The difference points are their shapes, colors, voice function, and measurement speed. The operation principle is based on thermosensor and ASIC technology. A thermistor is used as thermosensor. The ASIC gets the sensor's signal from human body, then processes the signal and calculates the result, after that displays the temperature result by a LCD. The digital thermometer comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature result.
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