NRV
- 产品代码
- NRV
- 器械名称
- Implantable Radio Frequency Transponder System
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 880.6300
- FDA 专业组
- General Hospital
- 上市路径
- 豁免 510(k)(仍须遵守通用控制与注册列名)
- 标记
- 属植入器械
- 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
An implantable microtransponder system intended to facilitate access to identification and health information in humans. It is described as consisting of a small implantable electronic microtransponder, an insertion device (introducer), and an electronic scanner (pocket reader). The microtransponder is a passive device that contains an electronic circuit, which is activated externally by a low-powered radio beam sent by a handheld, battery-powered pocket reader. The microtransponder stores only a unique electronic identification number (id). The id number is used to access a database that provides the implanted person's identity and health information supplied by the patient
FDA 官方分类页: NRV
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。