Cleared Traditional

Fitbit ECG App

K200948 · Fitbit, Inc. · Cardiovascular

Sep 2020

Decision

156d

Days

Class 2

Risk

About This 510(k) Submission

K200948 is an FDA 510(k) clearance for the Fitbit ECG App, a Electrocardiograph Software For Over-the-counter Use (Class II — Special Controls, product code QDA), submitted by Fitbit, Inc. (San Francisco, US). The FDA issued a Cleared decision on September 11, 2020, 156 days after receiving the submission on April 8, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2345.

Submission Details

510(k) Number	K200948 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 2020
Decision Date	September 11, 2020
Days to Decision	156 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.