DPS — Electrocardiograph Class II
FDA product code DPS covers "Electrocardiograph", a Class II medical device regulated under 21 CFR 870.2340. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DPS
- Device Class
- Class II
- Regulation Number
- 870.2340
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252463 | edan instruments | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | July 2, 2026 |
| K251670 | ge medical systems information technologies | MAC 7 Resting ECG Analysis System | January 26, 2026 |
| K252361 | accurkardia | AccurECG Analysis System (v2.0) | December 22, 2025 |
| K252474 | withings | Withings BeamO (SCT02) | November 10, 2025 |
| K250569 | philips france commercial | Cardiologs Holter Platform | August 6, 2025 |
| K243252 | zbeats | ZBPro Diagnostic | July 10, 2025 |
| K243305 | masimo corporation | Masimo W1 | April 3, 2025 |
| K241217 | inmedix | CloudHRV System (100-01-001) | January 16, 2025 |
| K241556 | philips medizin systeme böblingen | Cardiac Workstation (5000); Cardiac Workstation (7000) | December 17, 2024 |
| K240229 | masimo corporation | Masimo W1 | August 8, 2024 |
| K232161 | medicalgorithmics | DeepRhythm Platform | June 20, 2024 |
| K233266 | mediblu medical | MEDIBLU ECG SYSTEM | June 12, 2024 |
| K232816 | shenzhen le medical technology co | Electrocardiograph, model: ECG301 | June 7, 2024 |
| K232035 | alivecor | Impala | June 7, 2024 |
| K232445 | cardiacsense | CSF-4 (CSF-4) | May 2, 2024 |
| K232823 | amcg co | MCG-S (AM1000) | April 5, 2024 |
| K231160 | bionet co | Cardio Q50, Cardio Q70 | December 15, 2023 |
| K230834 | trismed co | CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H | November 21, 2023 |
| K232974 | ekgenius | EKGenius Smart System | November 17, 2023 |
| K232512 | masimo corporation | Masimo W1 | November 17, 2023 |