| 审查小组 | HO |
| 医学专业 | HO |
| 产品代码 | NRV |
| 设备名称 | Implantable Radio Frequency Transponder System |
| 器械分类等级 | 2 |
| 未分类原因 | |
| GMP豁免 | N |
| 第三方审核 | N |
| 审查代码 | |
| 法规编号 | 880.63 |
| 提交类型ID | 510(K) Exempt |
| 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 |
| 物理状态 | |
| 技术方法 | |
| 目标区域 | |
| 植入式 | Y |
| 维护生命设备 | N |