DPS · Electrocardiograph
Cardiovascular · 21 CFR 870.2340 · Class 2
Overview
| Product Code | DPS |
|---|---|
| Device Name | Electrocardiograph |
| Regulation | 21 CFR 870.2340 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 575)
Showing 20 most recent of 575 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251670 | MAC 7 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | Jan 26, 2026 | SESE |
| K252361 | AccurECG Analysis System (v2.0) | Accurkardia, Inc. | Dec 22, 2025 | SESE |
| K252474 | Withings BeamO (SCT02) | Withings | Nov 10, 2025 | SESE |
| K250569 | Cardiologs Holter Platform | Philips France Commercial | Aug 6, 2025 | SESE |
| K243252 | ZBPro Diagnostic | Zbeats, Inc. | Jul 10, 2025 | SESE |
| K243305 | Masimo W1 | Masimo Corporation | Apr 3, 2025 | SESE |
| K241217 | CloudHRV System (100-01-001) | Inmedix, Inc. | Jan 16, 2025 | SESE |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000) | Philips Medizin Systeme Böblingen GmbH | Dec 17, 2024 | SESE |
| K240229 | Masimo W1 | Masimo Corporation | Aug 8, 2024 | SESE |
| K232161 | DeepRhythm Platform | Medicalgorithmics S.A. | Jun 20, 2024 | SESE |
| K233266 | MEDIBLU ECG SYSTEM | Mediblu Medical, LLC | Jun 12, 2024 | SESE |
| K232816 | Electrocardiograph, model: ECG301 | Shenzhen LE Medical Technology Co., Ltd. | Jun 7, 2024 | SESE |
| K232035 | Impala | AliveCor, Inc. | Jun 7, 2024 | SESE |
| K232445 | CSF-4 (CSF-4) | Cardiacsense | May 2, 2024 | SESE |
| K232823 | MCG-S (AM1000) | Amcg Co., Ltd. | Apr 5, 2024 | SESE |
| K231160 | Cardio Q50, Cardio Q70 | Bionet Co., Ltd. | Dec 15, 2023 | SESE |
| K230834 | CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H | Trismed Co., Ltd. | Nov 21, 2023 | SESE |
| K232974 | EKGenius Smart System | Ekgenius, LLC | Nov 17, 2023 | SESE |
| K232512 | Masimo W1 | Masimo Corporation | Nov 17, 2023 | SESE |
| K231150 | Cardio P1 | Bionet Co., Ltd. | Nov 9, 2023 | SESE |
Top Applicants
- Mortara Instrument, Inc. — 21 clearances
- Nihon Kohden America, Inc. — 21 clearances
- Edan Instruments, Inc. — 18 clearances
- Quinton, Inc. — 17 clearances
- Hewlett-Packard Co. — 14 clearances
