QXQ
- 产品代码
- QXQ
- 器械名称
- Respiratory Accessory Microbial Reduction Device.
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 880.6993
- 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)
- 3 件
FDA 分类定义
A respiratory accessory microbial reduction device is a home-use device intended to be used as an adjunct for microbial reduction of compatible respiratory accessories,such as hoses and masks,after cleaning. This device is not intended to replace the original accessory manufacturers cleaning instructions.
该代码近三年的 510(k)(3 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K252471 | 2026-04-29 | LiViliti Health Products Corporation | Paptizer 360 | |
| K243815 | 2025-10-10 | Soclean, Inc. | SoClean 3+ | |
| DEN210037 | 2024-08-12 | Soclean, Inc. | SoClean 3+ Bacterial Reduction Device | — |
FDA 官方分类页: QXQ
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。