FDA product code OZK

Thermometer, Exhaled Breath

General Hospital·Class 2·21 CFR 880.2910
US regulatory classifications
US Product Code (FDA)
OZK
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 880.2910
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Medical specialty
General Hospital
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Thermometer, Exhaled Breath is a medical device type in the General Hospital specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.