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510(k) Data Aggregation
K Number
K111703Device Name
INFRARED EAR THEROMETER
Manufacturer
FUDAKANG INDUSTRIAL CO LTD
Date Cleared
2012-03-29
(286 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
FUDAKANG INDUSTRIAL CO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Infrared Thermometer (FT-F11) 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 Thermometer, (FT-F21, FT-F31, FT-F41) is intended for intermittent measurement of human body temperature in people of all ages.
Device Description
This infrared Ear Thermometer measure the temperature. It's from the ear canal which can be got more quickly and accurate the human body temperature.
This product has the following advantages:
1). Easy to Clean& Probe cover Free.
2). High speed & Accuracy scan the reading of temperature.
3). Conveniency, Only one key operation.
4). Automatic display last memorized measuring temperature. When do you turn on the power.
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