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