Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2920](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2920) → DXH — Transmitters And Receivers, Electrocardiograph, Telephone # DXH · Transmitters And Receivers, Electrocardiograph, Telephone _Cardiovascular · 21 CFR 870.2920 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH ## Overview - **Product Code:** DXH - **Device Name:** Transmitters And Receivers, Electrocardiograph, Telephone - **Regulation:** [21 CFR 870.2920](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2920) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 297) Showing 20 most recent of 297 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250233](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K250233.md) | PreemptiveAI Clinical SDK | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | Feb 13, 2026 | SESE | | [K250258](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K250258.md) | HeartBeam AIMIGo with 12-L ECG Synthesis Software System | Heartbeam, Inc. | Dec 8, 2025 | SESE | | [K243438](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K243438.md) | MEMO Patch M (MPT-E08R-UNC01) | Huinno Co., Ltd. | Dec 5, 2025 | SESE | | [K243981](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K243981.md) | Hexoskin Medical System (7100-00016) | Carre Technologies, Inc. | Nov 18, 2025 | SESE | | [K243003](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K243003.md) | VitalSigns 1-Lead Holter (VSH101) | VitalSigns Technology Co., Ltd. | Jun 17, 2025 | SESE | | [K233521](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K233521.md) | QT ECG (QTERD100) | QT Medical, Inc. | Dec 6, 2023 | SESE | | [K222842](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K222842.md) | V-Patch Cardiac Monitor | Shandong Corecare Technology Limited | Oct 20, 2022 | SESE | | [K220795](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K220795.md) | QT ECG | QT Medical, Inc. | Sep 26, 2022 | SESE | | [K213357](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K213357.md) | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor | Verily Life Sciences, LLC | Jul 19, 2022 | SESE | | [K220350](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K220350.md) | KardiaMobile 6L | AliveCor, Inc. | May 25, 2022 | SESE | | [K211668](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K211668.md) | KardiaMobile Card | AliveCor, Inc. | Nov 30, 2021 | SESE | | [K212160](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K212160.md) | SimpleSENSE Platform | Nanowear, Inc. | Sep 22, 2021 | SESE | | [K210753](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K210753.md) | KardiaMobile 6L | AliveCor, Inc. | Jun 30, 2021 | SESE | | [K201669](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K201669.md) | SimpleSENSE | Nanowear, Inc. | Nov 6, 2020 | SESE | | [K193296](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K193296.md) | eCordum Cardiac Monitor (eCordum CM) | Ecordum, Inc. | Oct 30, 2020 | SESE | | [K201208](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K201208.md) | Halo AF Detection System | Livmor | Sep 23, 2020 | SESE | | [K191406](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K191406.md) | KardiaMobile, KardiaStation | AliveCor, Inc. | Jan 24, 2020 | SESE | | [K192415](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K192415.md) | Study Watch with Irregular Pulse Monitor | Verily Life Sciences, LLC | Jan 17, 2020 | SESE | | [K183319](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K183319.md) | Triangle System | AliveCor, Inc. | May 10, 2019 | SESE | | [K182396](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K182396.md) | KardiaMobile, KardiaStation | AliveCor, Inc. | Apr 12, 2019 | SESE | ## Top Applicants - Card Guard Scientific Survival , Ltd. — 28 clearances - Instromedix, Inc. — 16 clearances - Medtronic Vascular — 15 clearances - AliveCor, Inc. — 10 clearances - Universal Medical, Inc. — 8 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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