OZK
- 产品代码
- OZK
- 器械名称
- Thermometer, Exhaled Breath
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 880.2910
- FDA 专业组
- General Hospital
- 上市路径
- 需提交 510(k) 上市前通告
FDA 分类定义
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.
FDA 官方分类页： OZK
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。