DPS
- Product code
- DPS
- Device name
- Electrocardiograph
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.2340
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 21
- Summaries archived here
- 18 (direct download)
- 510(k) clearances (all years, FDA)
- 576 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (21)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252463 | 2026-07-02 | Edan Instruments, Inc. | SE-1202 Series Electrocardiograph (Model: SE-1202, S… | |
| K251670 | 2026-01-26 | Ge Medical Systems Information Technol… | MAC 7 Resting ECG Analysis System | |
| K252361 | 2025-12-22 | Accurkardia, Inc. | AccurECG Analysis System (v2.0) | |
| K252474 | 2025-11-10 | Withings | Withings BeamO (SCT02) | FDA |
| K250569 | 2025-08-06 | Philips France Commercial | Cardiologs Holter Platform | |
| K243252 | 2025-07-10 | Zbeats, Inc. | ZBPro Diagnostic | |
| K243305 | 2025-04-03 | Masimo Corporation | Masimo W1 | |
| K241217 | 2025-01-16 | Inmedix, Inc. | CloudHRV System (100-01-001) | |
| K241556 | 2024-12-17 | Philips Medizin Systeme Böblingen GmbH | Cardiac Workstation (5000); Cardiac Workstation (700… | |
| K240229 | 2024-08-08 | Masimo Corporation | Masimo W1 | |
| K232161 | 2024-06-20 | Medicalgorithmics S.A. | DeepRhythm Platform | |
| K233266 | 2024-06-12 | Mediblu Medical, LLC | MEDIBLU ECG SYSTEM | |
| K232816 | 2024-06-07 | Shenzhen LE Medical Technology Co., Lt… | Electrocardiograph, model: ECG301 | |
| K232035 | 2024-06-07 | AliveCor, Inc. | Impala | |
| K232445 | 2024-05-02 | Cardiacsense | CSF-4 (CSF-4) | |
| K232823 | 2024-04-05 | Amcg Co., Ltd. | MCG-S (AM1000) | FDA |
| K231160 | 2023-12-15 | Bionet Co., Ltd. | Cardio Q50, Cardio Q70 | |
| K230834 | 2023-11-21 | Trismed Co., Ltd. | CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H | |
| K232512 | 2023-11-17 | Masimo Corporation | Masimo W1 | |
| K232974 | 2023-11-17 | Ekgenius, LLC | EKGenius Smart System | — |
| K231150 | 2023-11-09 | Bionet Co., Ltd. | Cardio P1 |
Official FDA classification page: DPS
Classification and pathway per current FDA publications. Data from openFDA (CC0).