NYK
- 产品代码
- NYK
- 器械名称
- Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 886.1385
- FDA 专业组
- Ophthalmic
- 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
Pmma diagnostic contact lens ophthalmodynamometer is intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis of intraocular abnormalities. The device is indicated for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eye with the contact lens. The device measures and displays the amount of force that is applied to the eye.
FDA 官方分类页： NYK
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。