PNA

Evoked Photon Image Capture Device

产品代码

PNA

器械名称

Evoked Photon Image Capture Device

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 882.1561

FDA 专业组

Neurology

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)

1 件

FDA 分类定义

The System reports two sets of numbers under two different conditions, one with capacitive barrier to minimize the effect of variables such as oils and sweat on the image and one without the capacitive barrier. The response scale reports numerical measures of electrophysiological signals emanating from the skin. The device is limited to use as a measurement tool and is not intended for diagnostic purposes or for influencing any clinical decisions. This device is only to be used to image and document electrophysiological signals emanating from the skin.

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）。