Cleared Traditional

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

K230292 · Samsung Electronics Co., Ltd. · Cardiovascular
May 2023
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K230292 is an FDA 510(k) clearance for the Samsung ECG Monitor Application with Irregular Heart Rhythm Notification, a Electrocardiograph Software For Over-the-counter Use (Class II — Special Controls, product code QDA), submitted by Samsung Electronics Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on May 2, 2023, 89 days after receiving the submission on February 2, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2345.

Submission Details

510(k) Number K230292 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2023
Decision Date May 02, 2023
Days to Decision 89 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.