NZH
- 产品代码
- NZH
- 器械名称
- Medication Management System, Remote
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 880.6315
- 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
A remote medication management system provides a means for the patient's prescribed medications to be stored in a delivery unit; For a medical provider to remotely schedule the patient's prescribed medications; To provide notification to the patient when the prescribed medications are due to be taken; To release the prescribed medications to a tray of the delivery unit accessible to the patient on the patient's command; And to provide to the medical provider a history of the event. The system is intended for use as an aid to medical providers in managing therapeutic regimens for patients in the home or clinic.
FDA 官方分类页: NZH
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。