OZK — Thermometer, Exhaled Breath Class II
FDA product code OZK covers "Thermometer, Exhaled Breath", a Class II medical device regulated under 21 CFR 880.2910. Submissions are reviewed by the General Hospital panel.
Classification Details
- Product Code
- OZK
- Device Class
- Class II
- Regulation Number
- 880.2910
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.