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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device thermometer, exhaled breath
Regulation Description Clinical electronic thermometer.
Definition To measure the temperature of exhaled human breath, which is frequently increased in airway inflammation in asthma patients. Measurement of changes in exhaled human breath temperature aids in evaluating airway inflammation treatment in asthma patients as an adjunct to established clinical and laboratory assessments of asthma.
Product CodeOZK
Regulation Number 880.2910
Device Class 2