Product code DXH
- Device name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2920
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250233 | PreemptiveAI Clinical SDK | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | 2026-02-13 |
| K250258 | HeartBeam AIMIGo with 12-L ECG Synthesis Software System | Heartbeam, Inc. | 2025-12-08 |
| K243438 | MEMO Patch M (MPT-E08R-UNC01) | Huinno Co., Ltd. | 2025-12-05 |
| K243981 | Hexoskin Medical System (7100-00016) | Carre Technologies, Inc. | 2025-11-18 |
| K243003 | VitalSigns 1-Lead Holter (VSH101) | VitalSigns Technology Co., Ltd. | 2025-06-17 |
| K233521 | QT ECG (QTERD100) | QT Medical, Inc. | 2023-12-06 |
| K222842 | V-Patch Cardiac Monitor | Shandong Corecare Technology Limited | 2022-10-20 |
| K220795 | QT ECG | QT Medical, Inc. | 2022-09-26 |
| K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor | Verily Life Sciences, LLC | 2022-07-19 |
| K220350 | KardiaMobile 6L | AliveCor, Inc. | 2022-05-25 |
| K211668 | KardiaMobile Card | AliveCor, Inc. | 2021-11-30 |
| K212160 | SimpleSENSE Platform | Nanowear, Inc. | 2021-09-22 |
| K210753 | KardiaMobile 6L | AliveCor, Inc. | 2021-06-30 |
| K201669 | SimpleSENSE | Nanowear, Inc. | 2020-11-06 |
| K193296 | eCordum Cardiac Monitor (eCordum CM) | Ecordum, Inc. | 2020-10-30 |
| K201208 | Halo AF Detection System | Livmor | 2020-09-23 |
| K191406 | KardiaMobile, KardiaStation | AliveCor, Inc. | 2020-01-24 |
| K192415 | Study Watch with Irregular Pulse Monitor | Verily Life Sciences, LLC | 2020-01-17 |
| K183319 | Triangle System | AliveCor, Inc. | 2019-05-10 |
| K182396 | KardiaMobile, KardiaStation | AliveCor, Inc. | 2019-04-12 |
| K181310 | HeartCheck Cardi Beat ECG Monitor with GEMS Mobile | Cardiocomm Solutions, Inc. | 2019-02-22 |
| K183704 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant, Inc. | 2019-02-16 |
| K182040 | Coala Heart Monitor | Coala Life AB | 2019-02-08 |
| K182456 | Study Watch | Verily Life Sciences, LLC | 2019-01-17 |
| K173589 | Prizma | G-Medical Innovations , Ltd. | 2018-11-30 |
| K173872 | FibriCheck | Qompium NV | 2018-09-28 |
| K173248 | CARDIOSKIN | Bioserenity Sas | 2018-08-11 |
| K180157 | QT ECG | QT Medical, Inc. | 2018-05-04 |
| K172311 | BioFlux Device | Biotricity, Inc. | 2017-12-15 |
| K171816 | Kardia Band System | AliveCor, Inc. | 2017-11-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08908013617128 | Frontier X Plus | FOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITED | 2025-02-07 |
| 10856602005267 | NA | PROTEUS DIGITAL HEALTH, INC. | 2019-07-12 |
| 10856602005250 | NA | PROTEUS DIGITAL HEALTH, INC. | 2019-07-12 |
| 10856602005243 | NA | PROTEUS DIGITAL HEALTH, INC. | 2019-07-12 |
| 10856602005236 | NA | PROTEUS DIGITAL HEALTH, INC. | 2019-07-12 |
| 10841522127212 | Lifecard | SPACELABS HEALTHCARE (WASHINGTON), INC | 2019-05-28 |
| 10841522125645 | Pathfinder | SPACELABS HEALTHCARE (WASHINGTON), INC | 2018-08-03 |
| 10841522124563 | Pathfinder | SPACELABS HEALTHCARE (WASHINGTON), INC | 2018-08-03 |
| 10856602005144 | Proteus Digital Health Feedback System | PROTEUS DIGITAL HEALTH, INC. | 2018-07-02 |
| 10841522123269 | Sentinel | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-08-15 |
| 10841522123252 | Sentinel | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-08-15 |
| 10841522123245 | Sentinel | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-08-15 |
| 10841522123221 | SENTINEL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-08-15 |
| 10841522123238 | Sentinel | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-08-15 |
| 10841522106941 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-06-21 |
| 10841522106934 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-06-21 |
| 10841522106903 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-06-21 |
| 10841522106897 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-06-21 |
| 10841522103094 | Sentinel | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-02-13 |
| 10841522103100 | Sentinel | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-02-13 |
| 10841522103117 | Sentinel | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-02-13 |
| 10841522103124 | SENTINEL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-02-13 |
| 10841522103131 | PathfinderSL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-02-13 |
| 10841522103452 | Sentinel | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-17 |
| 10856602005106 | NA | PROTEUS DIGITAL HEALTH, INC. | 2016-09-22 |
| 10856602005120 | NA | PROTEUS DIGITAL HEALTH, INC. | 2016-09-22 |
| 10856602005090 | NA | PROTEUS DIGITAL HEALTH, INC. | 2016-09-22 |
| 10856602005076 | NA | PROTEUS DIGITAL HEALTH, INC. | 2016-07-07 |
| 10856602005069 | NA | PROTEUS DIGITAL HEALTH, INC. | 2016-07-07 |
| 10856602005052 | NA | PROTEUS DIGITAL HEALTH, INC. | 2016-07-07 |