QGI
- 产品代码
- QGI
- 器械名称
- Air-Handling Apparatus Accessory
- 管理类别
- 第 1 类（Class I）
- 21 CFR 条款
- 21 CFR 878.5080
- 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
An air-handling apparatus accessory is a supplementary device that is intended to be used with an air-handling apparatus for a surgical operating room. This device provides an interface between the components of the device or can be used to switch electrical power. This generic type of device includes fittings, adapters, couplers, remote switches, and footswitches.
FDA 官方分类页： QGI
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。