DXQ
- 产品代码
- DXQ
- 器械名称
- Blood Pressure Cuff
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 870.1120
- FDA 专业组
- Cardiovascular
- 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)
- 199 件
FDA 分类定义
A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
该代码近三年的 510(k)（11 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K254287 | 2026-06-22 | Medline Industries, LP | Medline Reusable Blood Pressure Cuff 摘要 |
| K260747 | 2026-05-06 | Nihon Kohden Corporation | YP-710T Series NIBP Cuff;YP-840T Series Disposable C 摘要 |
| K253089 | 2026-02-13 | Shenzhen Best Electronics Co., Ltd. | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-5 摘要 |
| K253964 | 2026-01-09 | Unimed Medical Supplies, Inc. | Disposable Neonatal NIBP Cuff (U1681S-C51N) 摘要 |
| K251745 | 2025-12-16 | Baxter Healthcare Corporation | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPor 摘要 |
| K250765 | 2025-09-03 | Avita Corporation | AViTA Arm Type Blood Pressure Monitor Cuff 摘要 |
| K251045 | 2025-07-15 | Unimed Medical Supplies, Inc. | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposa 摘要 |
| K242623 | 2024-10-31 | Shenzhen Medke Technology Co., Ltd. | Disposable Blood Pressure cuff; Reusable Blood Press 摘要 |
| K240165 | 2024-03-20 | Wenzhou Longwan Medical Device Factory | Aneroid Sphygmomanometer with Stethoscope; Aneroid S 摘要 |
| K233276 | 2023-12-21 | Suzhou Minhua Medical Apparatus Suppli | Reusable Blood Pressure Cuff 摘要 |
| K232772 | 2023-11-29 | Shenzhen Plinma Technology Co. , Ltd. | Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,120 摘要 |
FDA 官方分类页： DXQ
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。