DXH
- Product code
- DXH
- Device name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.2920
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 297
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250233 | 2026-02-13 | Measure Labs, Inc. (Dba Preemptiveai, | PreemptiveAI Clinical SDK | |
| K250258 | 2025-12-08 | Heartbeam, Inc. | HeartBeam AIMIGo with 12-L ECG Synthesis Software Sy | |
| K243438 | 2025-12-05 | Huinno Co., Ltd. | MEMO Patch M (MPT-E08R-UNC01) | |
| K243981 | 2025-11-18 | Carre Technologies, Inc. | Hexoskin Medical System (7100-00016) | |
| K243003 | 2025-06-17 | VitalSigns Technology Co., Ltd. | VitalSigns 1-Lead Holter (VSH101) | |
| K233521 | 2023-12-06 | QT Medical, Inc. | QT ECG (QTERD100) |
Official FDA classification page: DXH
Classification and pathway per current FDA publications. Data from openFDA (CC0).