NHV
- 产品代码
- NHV
- 器械名称
- System, Water Purification, General Medical Use
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 876.5665
- FDA 专业组
- Gastroenterology, Urology
- 上市路径
- 需提交 510(k) 上市前通告
- FDA 历史累计 510(k)
- 11 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis. The difference lies with the intended use, as the proposed device is not intended for use in hemodialysis applications, for which a product code currently exists. Instead, the proposed device is intended for use to purify water for general purposes, including washing of surgeons hands, surgical instruments, and wound cleansing.
FDA 官方分类页： NHV
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。