DPS — Electrocardiograph Class II
FDA Device Classification
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 |
|---|
| 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 |
| K232035 | alivecor | Impala | June 7, 2024 |
| K232816 | shenzhen le medical technology co | Electrocardiograph, model: ECG301 | 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 |
| K232512 | masimo corporation | Masimo W1 | November 17, 2023 |
| K232974 | ekgenius | EKGenius Smart System | November 17, 2023 |
| K231150 | bionet co | Cardio P1 | November 9, 2023 |