NZH

Medication Management System, Remote

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.

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

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。