OBH
- 产品代码
- OBH
- 器械名称
- Monitor, Extracellular Fluid, Lymphedema, Extremity
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 870.2770
- FDA 专业组
- Cardiovascular
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 10 件
FDA 分类定义
Measure impedances in affected and unaffected but opposite extremity to periodically monitor the level of extracellular fluid or the differences in bioimpedance between opposing extremities for patients who have been previously diagnosed with unilateral lymphedema (that is, in one affected extremity)
该代码近三年的 510(k)(1 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253224 | 2026-01-28 | ImpediMed Limited | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) |
FDA 官方分类页: OBH
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。