QDA

Electrocardiograph Software For Over-The-Counter Use

Product code

QDA

Device name

Electrocardiograph Software For Over-The-Counter Use

Device class

Class 2

21 CFR

21 CFR 870.2345

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

3

Summaries archived here

3 (direct download)

510(k) clearances (all years, FDA)

9 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-06-15.

3 summaries are archived here for direct download.