FDA.reportPublic FDA data

Cardiac electrophysiology application software

Definition
A software program designed to add specific image processing and/or data analysis capabilities to a computer for the interpretation of cardiac electrophysiology parameters [e.g., electrocardiogram (ECG)]. It may provide risk assessment for cardiac events [e.g., acute myocardial infarction (AMI), acute myocardial ischemic injury (AMII)] and/or include the ability to record images and movies.
GUDID devices
15
Last updated
2022-11-07 09:23:40

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08885018690014RhythmAnalyticsBIOFOURMIS SINGAPORE PTE. LTD.1.12022-10-28
B273CEA0Cardiologs PlatformCARDIOLOGS TECHNOLOGIES2.1.xx2021-12-08
00190199649286ECG 2.0 AppAPPLE INC.Feature Version 2.x2020-12-15
00190199649293ECG 2.0 AppAPPLE INC.Feature Version 2.x2020-12-15
00191506004392LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONM004LSPRO4001002020-10-26
08714729975700LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONM004200206202018-09-24
00810038851983Fitbit ECG AppFitbit LLCFB6032020-10-07
00850010298030Eko Analysis SoftwareEko Devices, Inc.EAS2020-09-08
B320CF190Premier Heart MCGPREMIER HEART, LLCCF192016-09-27
B320MCGC0Premier Heart MCG Analysis SoftwarePREMIER HEART, LLCMCGC2018-05-17
00857175006029VectraplexECG SystemVECTRACOR INC3.4.22016-09-26
00857175006166Office MedicVECTRACOR INC6.02017-01-23
00190198909510Irregular Rhythm NotificationsAPPLE INC.Feature Version 1.x2019-01-14
00190198909534ECG AppAPPLE INC.Feature Version 1.x2019-01-14
00190198909541ECG AppAPPLE INC.Feature Version 1.x2019-01-14