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DXH

Transmitters And Receivers, Electrocardiograph, Telephone

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)
6
Summaries archived here
6 (direct download)
510(k) clearances (all years, FDA)
297 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (6)

Last three years. Most recent: 2026-02-13.

NumberDecision dateApplicantDevice nameSummary
K2502332026-02-13Measure Labs, Inc. (Dba Preemptiveai, …PreemptiveAI Clinical SDKPDF
K2502582025-12-08Heartbeam, Inc.HeartBeam AIMIGo with 12-L ECG Synthesis Software Sy…PDF
K2434382025-12-05Huinno Co., Ltd.MEMO Patch M (MPT-E08R-UNC01)PDF
K2439812025-11-18Carre Technologies, Inc.Hexoskin Medical System (7100-00016)PDF
K2430032025-06-17VitalSigns Technology Co., Ltd.VitalSigns 1-Lead Holter (VSH101)PDF
K2335212023-12-06QT Medical, Inc.QT ECG (QTERD100)PDF

6 summaries are archived here for direct download.

Official FDA classification page: DXH
Classification and pathway per current FDA publications. Data from openFDA (CC0).