Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2340](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2340) → DPS — Electrocardiograph # DPS · Electrocardiograph _Cardiovascular · 21 CFR 870.2340 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS ## Overview - **Product Code:** DPS - **Device Name:** Electrocardiograph - **Regulation:** [21 CFR 870.2340](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2340) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **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](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K251670.md) | MAC 7 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | Jan 26, 2026 | SESE | | [K252361](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K252361.md) | AccurECG Analysis System (v2.0) | Accurkardia, Inc. | Dec 22, 2025 | SESE | | [K252474](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K252474.md) | Withings BeamO (SCT02) | Withings | Nov 10, 2025 | SESE | | [K250569](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K250569.md) | Cardiologs Holter Platform | Philips France Commercial | Aug 6, 2025 | SESE | | [K243252](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K243252.md) | ZBPro Diagnostic | Zbeats, Inc. | Jul 10, 2025 | SESE | | [K243305](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K243305.md) | Masimo W1 | Masimo Corporation | Apr 3, 2025 | SESE | | [K241217](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K241217.md) | CloudHRV™ System (100-01-001) | Inmedix, Inc. | Jan 16, 2025 | SESE | | [K241556](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K241556.md) | Cardiac Workstation (5000); Cardiac Workstation (7000) | Philips Medizin Systeme Böblingen GmbH | Dec 17, 2024 | SESE | | [K240229](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K240229.md) | Masimo W1 | Masimo Corporation | Aug 8, 2024 | SESE | | [K232161](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K232161.md) | DeepRhythm Platform | Medicalgorithmics S.A. | Jun 20, 2024 | SESE | | [K233266](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K233266.md) | MEDIBLU ECG SYSTEM | Mediblu Medical, LLC | Jun 12, 2024 | SESE | | [K232816](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K232816.md) | Electrocardiograph, model: ECG301 | Shenzhen LE Medical Technology Co., Ltd. | Jun 7, 2024 | SESE | | [K232035](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K232035.md) | Impala | AliveCor, Inc. | Jun 7, 2024 | SESE | | [K232445](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K232445.md) | CSF-4 (CSF-4) | Cardiacsense | May 2, 2024 | SESE | | [K232823](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K232823.md) | MCG-S (AM1000) | Amcg Co., Ltd. | Apr 5, 2024 | SESE | | [K231160](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K231160.md) | Cardio Q50, Cardio Q70 | Bionet Co., Ltd. | Dec 15, 2023 | SESE | | [K230834](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K230834.md) | CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H | Trismed Co., Ltd. | Nov 21, 2023 | SESE | | [K232974](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K232974.md) | EKGenius Smart System | Ekgenius, LLC | Nov 17, 2023 | SESE | | [K232512](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K232512.md) | Masimo W1 | Masimo Corporation | Nov 17, 2023 | SESE | | [K231150](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K231150.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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