Cleared Traditional

ECG App

K201525 · Apple, Inc. · Cardiovascular

Oct 2020

Decision

122d

Days

Class 2

Risk

About This 510(k) Submission

K201525 is an FDA 510(k) clearance for the ECG App, a Electrocardiograph Software For Over-the-counter Use (Class II — Special Controls, product code QDA), submitted by Apple, Inc. (Cupertino, US). The FDA issued a Cleared decision on October 8, 2020, 122 days after receiving the submission on June 8, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2345.

Submission Details

510(k) Number	K201525 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 2020
Decision Date	October 08, 2020
Days to Decision	122 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.