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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State The major components of the device are: a. A 0.5-litre silver plated flask in a metal cylinder (thermos) b. An air tube and thermal block made out of copper with an in-built temperature sensor. The thermal block has a tube-like part with high thermal capacity and excellent heat conduction properties c. Mouthpiece (Polypropylene) d. Inlet Cap (Polycarbonate) e. USB Port (Polyurethane) f. Environmental Chamber (Mild Sheet Metal) g. LCD Screen h. Navigation/Power/OK buttons (ABS)
Technical Method The essence of the device technology is an environmental chamber with a thermal core heated by exhaled air from the patient. Each exhalation increases the temperature inside the reservoir until equilibrium is reached and measured by a thermal sensor. To use the device, the patient inhales through the nose and exhales into the device via a mouthpiece. The temperature in the device is assessed by measuring the resistance of the thermal sensor by means of a digital ohm-meter.
Target Area Mouth
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeOZK
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.2910
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible