OZK

Thermometer, Exhaled Breath

Product code

OZK

Device name

Thermometer, Exhaled Breath

Device class

Class 2

21 CFR

21 CFR 880.2910

Medical specialty

General Hospital

Marketing pathway

510(K)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).