QXC
- 产品代码
- QXC
- 器械名称
- Diabetes Digital Therapeutic Device
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 880.5735
- FDA 专业组
- General Hospital
- 上市路径
- 需提交 510(k) 上市前通告
- FDA 历史累计 510(k)
- 1 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
A diabetes digital behavioral therapeutic device is a prescription use software device that provides digital behavioral therapy to aid in the management of diabetes. This device is intended to provide limited secondary benefit to patients with diabetes mellitus by assisting them in managing their condition. This device is not intended to replace any primary treatment, such as diet/lifestyle changes or medication.
FDA 官方分类页： QXC
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。