DPS
- 产品代码
- DPS
- 器械名称
- Electrocardiograph
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 870.2340
- 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)
- 576 件
该代码近三年的 510(k)（21 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K252463 | 2026-07-02 | Edan Instruments, Inc. | SE-1202 Series Electrocardiograph (Model: SE-1202, S 摘要 |
| K251670 | 2026-01-26 | Ge Medical Systems Information Technol | MAC 7 Resting ECG Analysis System 摘要 |
| K252361 | 2025-12-22 | Accurkardia, Inc. | AccurECG Analysis System (v2.0) 摘要 |
| K252474 | 2025-11-10 | Withings | Withings BeamO (SCT02) 摘要 |
| K250569 | 2025-08-06 | Philips France Commercial | Cardiologs Holter Platform 摘要 |
| K243252 | 2025-07-10 | Zbeats, Inc. | ZBPro Diagnostic 摘要 |
| K243305 | 2025-04-03 | Masimo Corporation | Masimo W1 摘要 |
| K241217 | 2025-01-16 | Inmedix, Inc. | CloudHRV System (100-01-001) 摘要 |
| K241556 | 2024-12-17 | Philips Medizin Systeme Böblingen GmbH | Cardiac Workstation (5000); Cardiac Workstation (700 摘要 |
| K240229 | 2024-08-08 | Masimo Corporation | Masimo W1 摘要 |
| K232161 | 2024-06-20 | Medicalgorithmics S.A. | DeepRhythm Platform 摘要 |
| K233266 | 2024-06-12 | Mediblu Medical, LLC | MEDIBLU ECG SYSTEM 摘要 |
| K232816 | 2024-06-07 | Shenzhen LE Medical Technology Co., Lt | Electrocardiograph, model: ECG301 摘要 |
| K232035 | 2024-06-07 | AliveCor, Inc. | Impala 摘要 |
| K232445 | 2024-05-02 | Cardiacsense | CSF-4 (CSF-4) 摘要 |
| K232823 | 2024-04-05 | Amcg Co., Ltd. | MCG-S (AM1000) 摘要 |
| K231160 | 2023-12-15 | Bionet Co., Ltd. | Cardio Q50, Cardio Q70 摘要 |
| K230834 | 2023-11-21 | Trismed Co., Ltd. | CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H 摘要 |
| K232512 | 2023-11-17 | Masimo Corporation | Masimo W1 摘要 |
| K232974 | 2023-11-17 | Ekgenius, LLC | EKGenius Smart System |
| K231150 | 2023-11-09 | Bionet Co., Ltd. | Cardio P1 摘要 |
FDA 官方分类页： DPS
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。