MUA
- 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
- FDA 历史累计 510(k)
- 9 件（全部年份；本站只收录近三年的明细）
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
FDA 官方分类页： MUA
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。