Product code OZK

Device name

Thermometer, Exhaled Breath

Medical specialty

General Hospital

Device class

2

Regulation number

880.2910

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset