QVE

Adjunctive Pain Measurement Device For Anesthesiology

产品代码

QVE

器械名称

Adjunctive Pain Measurement Device For Anesthesiology

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 868.2200

FDA 专业组

Anesthesiology

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

An adjunctive pain measurement device for anesthesiology is a prescription device that includes software algorithms to analyze physiological sensor data and measure response to painful stimuli in patients under general anesthesia. The device may be software-only or it may include hardware such as physiological sensors. This device type is intended for adjunctive use to tailor analgesic administration to a patient’s actual response to painful stimuli and is not intended to independently direct decision-making.

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）。