QGX
- 产品代码
- QGX
- 器械名称
- General Use Pneumatic Tourniquet
- 管理类别
- 第 1 类(Class I)
- 21 CFR 条款
- 21 CFR 878.5910
- FDA 专业组
- General, Plastic Surgery
- 上市路径
- 豁免 510(k)(仍须遵守通用控制与注册列名)
FDA 分类定义
A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation.
FDA 官方分类页: QGX
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。