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QDA — Electrocardiograph Software For Over-The-Counter Use Class II

FDA Device Classification

Classification Details

Product Code
QDA
Device Class
Class II
Regulation Number
870.2345
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240795withingsWithings ECG AppJune 15, 2025
K243236whoopWHOOP ECG (electrocardiogram) Feature (1.0)April 4, 2025
K240909samsung electronics coSamsung ECG App v 1.3 (ECG)August 2, 2024
K230292samsung electronics coSamsung ECG Monitor Application with Irregular Heart Rhythm NotificationMay 2, 2023
K221774garmin internationalGarmin ECG AppJanuary 12, 2023
K201525appleECG AppOctober 8, 2020
K200948fitbitFitbit ECG AppSeptember 11, 2020
K201168samsung electronics coECG Monitor AppAugust 4, 2020
DEN180044appleECG AppSeptember 11, 2018