OUG
- 产品代码
- OUG
- 器械名称
- Medical Device Data System
- 管理类别
- 第 1 类（Class I）
- 21 CFR 条款
- 21 CFR 880.6310
- FDA 专业组
- General Hospital
- 上市路径
- 豁免 510(k)（仍须遵守通用控制与注册列名）
- FDA 历史累计 510(k)
- 1 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) the electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring.