FDA product code OZK: Thermometer, Exhaled Breath
OZK is the FDA product code for thermometer, exhaled breath. It is a Class II device, regulated under 21 CFR 880.2910 and reviewed by the General Hospital panel. Devices under OZK reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Thermometer, Exhaled Breath |
| Device class | Class II |
| Regulation | 21 CFR 880.2910 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Recalls for OZK devices
openFDA lists no recalls for product code OZK.
Frequently asked questions
What is FDA product code OZK?
OZK is the FDA product code for thermometer, exhaled breath. It is a Class II device, regulated under 21 CFR 880.2910 and reviewed by the General Hospital panel.
What device class is OZK?
Class II, regulation 21 CFR 880.2910. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OZK
- Run a recall and safety report across every OZK manufacturer
- Watch product code OZK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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