Cleared Traditional

Garmin ECG App

K221774 · Garmin International, Inc. · Cardiovascular

Jan 2023

Decision

205d

Days

Class 2

Risk

About This 510(k) Submission

K221774 is an FDA 510(k) clearance for the Garmin ECG App, a Electrocardiograph Software For Over-the-counter Use (Class II — Special Controls, product code QDA), submitted by Garmin International, Inc. (Olathe, US). The FDA issued a Cleared decision on January 12, 2023, 205 days after receiving the submission on June 21, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2345.

Submission Details

510(k) Number	K221774 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2022
Decision Date	January 12, 2023
Days to Decision	205 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QDA — Electrocardiograph Software For Over-the-counter Use
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2345
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.