PJT
- 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
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。