FDA.reportPublic FDA data

Electrocardiograph, professional, single-channel

Definition
A device intended to be used by a healthcare professional in a clinical setting to record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed to record the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel) but may otherwise include a variety of additional features [e.g., interpretive software, data telemetry, display screen]; electrodes may be included. It is intended to be used by a healthcare professional in a clinical setting.
GUDID devices
25
Last updated
2020-12-21 08:32:44

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
09353278000465Kosmos Accessories - US - RefurbishedECHONOUS, INC.R0062082020-12-11
008643590002303CPM Company, Inc.3CPM CO., INC.1.022020-08-18
008643590002473CPM Company, Inc.3CPM CO., INC.2.09g2020-08-18
008643590002543CPM Company, Inc.3CPM CO., INC.12020-08-18
008643590002613CPM Company, Inc.3CPM CO., INC.12020-08-18
008643590002783CPM Company, Inc.3CPM CO., INC.12020-08-18
008643590002853CPM Company, Inc.3CPM CO., INC.2.09g2020-08-18
008643590002923CPM Company, Inc.3CPM CO., INC.2.09g2020-08-18
09353278000144Kosmos ECG Patient Cable - USECHONOUS, INC.P0057792020-05-06
09353278000243Kosmos ECG Patient Cable - InternationalECHONOUS, INC.P0061862020-05-06
09353278000250Kosmos Accessories - InternationalECHONOUS, INC.P0061052020-05-06
09353278000267Kosmos Accessories - USECHONOUS, INC.P0062082020-05-06
00840682110075CAMGE Medical Systems Information Technologies, Inc.142016-05-13
00840682112406CAMGE Medical Systems Information Technologies, Inc.HD2016-05-13
00860002827315MobileECG SystemMEMTEC CORPORATIONMobileECG System2019-11-15
06430035220151FarosBittium Biosignals OyFaros 902016-09-22
06430035220168FarosBittium Biosignals OyFaros 1802016-09-22
06430035220229eMotion ECGBittium Biosignals OyeMotion ECG sensor2016-09-22
06945040100065CONTECContec Medical Systems Co., Ltd.ECG80A2016-09-24
06945040100072CONTECContec Medical Systems Co., Ltd.ECG100G2016-09-24
00856298006077Telemetry 3 Lead Patient CableSCOTTCARE CORPORATION, THETelemetry 3 Lead Patient Cable2016-09-19
008643590002093CPM Company, Inc3CPM CO., INC.2.09e2016-09-27
008643590002163CPM Company, Inc3CPM CO., INC.2.09e2016-09-27
008643590002233CPM Company, Inc3CPM CO., INC.2.09e2016-09-27
00812324000020HeartCheck BT PEN Handheld ECGCardioComm Solutions, IncHCEKGBTPEN302017-11-28