DXH — Transmitters And Receivers, Electrocardiograph, Telephone Class II
FDA Device Classification
Classification Details
- Product Code
- DXH
- Device Class
- Class II
- Regulation Number
- 870.2920
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250233 | measure labs, inc. (dba preemptiveai, inc.) | PreemptiveAI Clinical SDK | February 13, 2026 |
| K250258 | heartbeam | HeartBeam AIMIGo with 12-L ECG Synthesis Software System | December 8, 2025 |
| K243438 | huinno co | MEMO Patch M (MPT-E08R-UNC01) | December 5, 2025 |
| K243981 | carre technologies | Hexoskin Medical System (7100-00016) | November 18, 2025 |
| K243003 | vitalsigns technology co | VitalSigns 1-Lead Holter (VSH101) | June 17, 2025 |
| K233521 | qt medical | QT ECG (QTERD100) | December 6, 2023 |
| K222842 | shandong corecare technology limited | V-Patch Cardiac Monitor | October 20, 2022 |
| K220795 | qt medical | QT ECG | September 26, 2022 |
| K213357 | verily life sciences | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Puls | July 19, 2022 |
| K220350 | alivecor | KardiaMobile 6L | May 25, 2022 |
| K211668 | alivecor | KardiaMobile Card | November 30, 2021 |
| K212160 | nanowear | SimpleSENSE Platform | September 22, 2021 |
| K210753 | alivecor | KardiaMobile 6L | June 30, 2021 |
| K201669 | nanowear | SimpleSENSE | November 6, 2020 |
| K193296 | ecordum | eCordum Cardiac Monitor (eCordum CM) | October 30, 2020 |
| K201208 | livmor | Halo AF Detection System | September 23, 2020 |
| K191406 | alivecor | KardiaMobile, KardiaStation | January 24, 2020 |
| K192415 | verily life sciences | Study Watch with Irregular Pulse Monitor | January 17, 2020 |
| K183319 | alivecor | Triangle System | May 10, 2019 |
| K182396 | alivecor | KardiaMobile, KardiaStation | April 12, 2019 |