NJJ

Tonometer, Analyzer, Ocular Blood Flow

产品代码

NJJ

器械名称

Tonometer, Analyzer, Ocular Blood Flow

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 886.1930

FDA 专业组

Ophthalmic

上市路径

需提交 510(k) 上市前通告

标记

可走第三方审查

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

Tonometry for measuring and recording intraocular pressures and intraocular pulse amplitudes, pulsatile ocular blood flow, pulsatile ocular blood volume, pulsatility index equivalent. Description of why current product c lassificaiton name/product code will not suffice: This device measures intraocular pressure, which is what a tonometer does. However, because it can measure the small changes in pressure caused by the blood pressure pulse in the ocular arterial vessels, it is also capable of measuring and calculating parameters associated with the ocular blood flow, including intraocular pressure pulse amplitude, pulsatile ocular blood flow, and pulsatile ocular blood volume.

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）。