NSC
- 产品代码
- NSC
- 器械名称
- Injector, Pen
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 880.5860
- FDA 专业组
- General Hospital
- 上市路径
- 需提交 510(k) 上市前通告
- 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 pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of medicinal product from a medicinal cartridge, reservoir, or syringe through a manually-inserted single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient.
FDA 官方分类页： NSC
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。