SCS
- 产品代码
- SCS
- 器械名称
- Ultraviolet Radiation Disinfection Chamber Device
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 880.6511
- FDA 专业组
- General Hospital
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 2 件
FDA 分类定义
An ultraviolet radiation disinfection chamber device is intended to disinfect patient contacting medical devices using UV radiation after the device has been cleaned. Disinfection of the medical device is achieved within an enclosed chamber through the exposure to UV radiation.
该代码近三年的 510(k)(2 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K251354 | 2026-01-29 | UV Smart Technologies B.V. | UV Smart D60 | |
| DEN230067 | 2024-08-28 | Germitec | Chronos® | — |
FDA 官方分类页: SCS
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。