FDA 510(k) Applications for Medical Device Product Code "QDA"

FDA 510(k) Number Applicant Device Name Decision Date
DEN180044 Apple Inc ECG App 09/11/2018
K201525 Apple Inc. ECG App 10/08/2020
K200948 Fitbit, Inc. Fitbit ECG App 09/11/2020
K221774 Garmin International, Inc. Garmin ECG App 01/12/2023
K201168 Samsung Electronics Co., Ltd ECG Monitor App 08/04/2020
K230292 Samsung Electronics Co., Ltd Samsung ECG Monitor Application with Irregular Heart Rhythm Notification 05/02/2023


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact