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510(k) Data Aggregation
K Number
K103839Device Name
BEHIND EAR GENTLE TOUCH THERMOMETER
Manufacturer
Date Cleared
2011-06-06
(158 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
KAZ, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Behind Ear Gentle Touch Thermometer (Models V980/BET 1000) is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature using behind the earlobe as the measurement site on people of all ages.
Device Description
The over-the-counter Behind Ear Gentle Touch Thermometer - Models V980/ BET 1000 is a hand-held, battery powered device designed to measure human body temperature by detecting heat flow on the skin directly behind the ear lobe as a measurement site, by using the heat conduction principal and prediction. The skin area over the posterior auricular artery passing behind the earlobe is the measurement site, which is very close to the cantharid artery. These arteries carry blood to the brain and therefore the site is the best external place to measure temperature. The Behind Ear Gentle Touch Thermometer is designed to calculate the maximum temperature of a probe in contact with the body site by heat transfer data and mathematical algorithm. The temperature reading range is from 95.0° F to 107.6° F (35°C to 42 °C) and the time of measurement is about 1 second.
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