MUA

Bone Sonometer

产品代码

MUA

器械名称

Bone Sonometer

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 892.1180

FDA 专业组

Radiology

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

9 件

FDA 分类定义

A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal. Reclassified from class 3 pma to class 2 510(k) 892.1180 [docket no. Fda-2005-n-0346] reclassification of bone sonometers

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）。