PIR

Mercy Tape 2d And 3d Models

产品代码

PIR

器械名称

Mercy Tape 2d And 3d Models

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 878.4800

FDA 专业组

General, Plastic Surgery

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)

2 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

The Mercy TAPE device (2D and 3D models) is intended for use by health care professionals to estimate the body weight of pediatric patients between the ages of 2 months and 16 years, using linear measurements from specific anatomical landmarks made with the TAPE device for humeral length (HL, for the 2D model) or half-humeral length (HHL, for the 3D model) and the mid-upper arm circumference (MUAC).

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）。