OBN

Humidifier, Respiratory, Mask (Direct Patient Interface)

产品代码

OBN

器械名称

Humidifier, Respiratory, Mask (Direct Patient Interface)

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 868.5450

FDA 专业组

Anesthesiology

上市路径

需提交 510(k) 上市前通告

标记

可走第三方审查

该代码近三年的 510(k)

1 件

FDA 分类定义

Intended to moderate blood pressure in hypertensive patients when they are exposed to the cold. The mask attenuates (moderates) the physiological response, increases in blood pressure, associated with cold exposure, by warming the inhaled air during cold exposure for individuals with hypertension, medicated or non-medicated.

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）。