FDA Product Code QDA: Electrocardiograph Software For Over-the-counter Use
An Electrocardiograph Software Device For Over-the-counter Use Creates, Analyzes, And Displays Electrocardiograph Data, And Can Provide Information For Identifying Cardiac Arrhythmias. This Device Is Not Intended To Provide A Diagnosis.
Leading manufacturers include Samsung Electronics Co., Ltd..
List of Electrocardiograph Software For Over-the-counter Use devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Electrocardiograph Software For Over-the-counter Use devices (product code QDA). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →