PJT

Continuous Glucose Monitor Secondary Display

产品代码
PJT
器械名称
Continuous Glucose Monitor Secondary Display
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 862.1350
FDA 专业组
Clinical Chemistry
上市路径
豁免 510(k)(仍须遵守通用控制与注册列名)
该代码近三年的 510(k)
2 件

FDA 分类定义

The purpose of the continuous glucose monitor secondary display is to notify another person, the follower, of the patient's continuous glucose monitoring system sensor glucose information in real time. The secondary display is intended for providing secondary notification of a continuous glucose monitoring system and does not replace primary real time continuous glucose monitoring or standard home blood glucose monitoring

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: PJT
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。