DXH · Transmitters And Receivers, Electrocardiograph, Telephone
Cardiovascular · 21 CFR 870.2920 · Class 2
Overview
| Product Code | DXH |
|---|---|
| Device Name | Transmitters And Receivers, Electrocardiograph, Telephone |
| Regulation | 21 CFR 870.2920 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | PreemptiveAI Clinical SDK | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | Feb 13, 2026 | SESE |
| K250258 | HeartBeam AIMIGo with 12-L ECG Synthesis Software System | Heartbeam, Inc. | Dec 8, 2025 | SESE |
| K243438 | MEMO Patch M (MPT-E08R-UNC01) | Huinno Co., Ltd. | Dec 5, 2025 | SESE |
| K243981 | Hexoskin Medical System (7100-00016) | Carre Technologies, Inc. | Nov 18, 2025 | SESE |
| K243003 | VitalSigns 1-Lead Holter (VSH101) | VitalSigns Technology Co., Ltd. | Jun 17, 2025 | SESE |
| K233521 | QT ECG (QTERD100) | QT Medical, Inc. | Dec 6, 2023 | SESE |
| K222842 | V-Patch Cardiac Monitor | Shandong Corecare Technology Limited | Oct 20, 2022 | SESE |
| K220795 | QT ECG | QT Medical, Inc. | Sep 26, 2022 | SESE |
| K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor | Verily Life Sciences, LLC | Jul 19, 2022 | SESE |
| K220350 | KardiaMobile 6L | AliveCor, Inc. | May 25, 2022 | SESE |
| K211668 | KardiaMobile Card | AliveCor, Inc. | Nov 30, 2021 | SESE |
| K212160 | SimpleSENSE Platform | Nanowear, Inc. | Sep 22, 2021 | SESE |
| K210753 | KardiaMobile 6L | AliveCor, Inc. | Jun 30, 2021 | SESE |
| K201669 | SimpleSENSE | Nanowear, Inc. | Nov 6, 2020 | SESE |
| K193296 | eCordum Cardiac Monitor (eCordum CM) | Ecordum, Inc. | Oct 30, 2020 | SESE |
| K201208 | Halo AF Detection System | Livmor | Sep 23, 2020 | SESE |
| K191406 | KardiaMobile, KardiaStation | AliveCor, Inc. | Jan 24, 2020 | SESE |
| K192415 | Study Watch with Irregular Pulse Monitor | Verily Life Sciences, LLC | Jan 17, 2020 | SESE |
| K183319 | Triangle System | AliveCor, Inc. | May 10, 2019 | SESE |
| K182396 | 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
