DXH — Transmitters And Receivers, Electrocardiograph, Telephone Class II
FDA product code DXH covers "Transmitters And Receivers, Electrocardiograph, Telephone", a Class II medical device regulated under 21 CFR 870.2920. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |