FDA.reportPublic FDA data

Electrocardiograph, professional, single-channel

Definition
A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel). It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or data telemetry features might also be included.
GUDID devices
31
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00856298006381Aermos Tx DeviceScottCare Cardiovascular Solutions1022012025-10-28
00856298006442Aermos Tx Patiet CableScottCare Cardiovascular Solutions1022052025-10-28
10884521704817ZephyrZEPHYR TECHNOLOGY LLCBH3-M12016-10-13
10884521725461ZephyrZEPHYR TECHNOLOGY LLCBH3-M22018-01-24
00850044849086Vivio System EKG PatchVentric Health2500222025-09-08
B210AC0290K1000Alivecor, Inc.AC-0292025-03-18
08690020003017VitalScan ANSMedeia, Inc.HW102025-02-05
00860007764424EKG Patch SolutionMg Medical Products LLC12025-01-09
00198715993158EKG Patch SolutionMg Medical Products LLC12024-12-19
B210AC0110KardiaBand SystemAlivecor, Inc.AC-0112024-03-22
00850033167177Total ECGGlobalmed Holdings, LLCGMD506100012023-12-08
00850044849017Vivio System EKG PatchVentric HealthVP 1.02023-11-22
10884521712935ZephyrLIFE HomeZEPHYR TECHNOLOGY LLC9607.02422016-09-24
10884521712942ZephyrLIFE HomeZEPHYR TECHNOLOGY LLC9607.02432016-09-24
10884521712966ZephyrLIFE HomeZEPHYR TECHNOLOGY LLC9607.02452016-09-24
10884521712973ZephyrLIFE HomeZEPHYR TECHNOLOGY LLC9607.02462016-09-24
10884521712980ZephyrLIFE HomeZEPHYR TECHNOLOGY LLC9607.02582016-09-24
10884521712997ZephyrLIFE HomeZEPHYR TECHNOLOGY LLC9607.02572016-09-24
10884521712959ZephyrLIFE HomeZEPHYR TECHNOLOGY LLC9607.02442016-09-24
10884521713000ZephyrLIFE HomeZEPHYR TECHNOLOGY LLC9607.02592016-09-24
06942820462320ChoicemmedBeijing Choice Electronic Technology Co., Ltd.MD100A1-F2023-08-23
10884521712911ZephyrLIFE HomeZEPHYR TECHNOLOGY LLC9607.02392016-09-24
10884521712928ZephyrLIFE HomeZEPHYR TECHNOLOGY LLC9607.02412016-09-24
B210AC0210KardiaMobile CardAlivecor, Inc.AC-0212022-07-13
03760232460177HFVi monitorMDOLORIS MEDICAL SYSTEMSV1 2016-12-21
03760232460184BA-HFVI-V1MDOLORIS MEDICAL SYSTEMSV12019-01-10
08809475370005Make a Way PREGNANT WOMEN & FETAL HEALTH MONITORMAKE A WAY CO.,LTD.BBSMT012017-06-13
08809475370012Make a Way ECG MonitorMAKE A WAY CO.,LTD.MAW20172017-07-05
10884521758964ZephyrZEPHYR TECHNOLOGY LLC9607-02182018-01-24
10884521758995ZephyrZEPHYR TECHNOLOGY LLC9607-02152018-01-24
90884521725467ZephyrZEPHYR TECHNOLOGY LLCBH3-M22018-01-24