QLV
- 产品代码
- QLV
- 器械名称
- Field Generator Positioning Device
- 管理类别
- 第 1 类(Class I)
- 21 CFR 条款
- 21 CFR 882.4565
- FDA 专业组
- Neurology
- 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 accessory or a group of accessories that operate independently or adapt existing medical equipment, such as a procedure chair or surgical bed, to manually position the Field Generator of a Navigation System in proximity to a patient.
FDA 官方分类页: QLV
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。