审查小组
SU
医学专业
SU
产品代码
NRB
设备名称
Wound Cleaner, Ultrasound
器械分类等级
2
未分类原因
GMP豁免
N
第三方审核
Y
审查代码
法规编号
878.441
提交类型ID
510(K)
定义
The ultrasound wound cleaner/mild debridement system is a device that delivers a cleaning fluid to the wound that is pulsed using low power ultrasound radiation. The device is intended to clean and mildly debride wounds. The ultrasound generator must deliver 1.0 mw/cm2 or less energy to the wound
物理状态
技术方法
目标区域
植入式
N
维护生命设备
N