Devices · Samsung Electronics Co., Ltd

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

Samsung Electronics Co., Ltd is listed for Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (K230292). The FDA list gives May 2, 2023 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QDA as “Electrocardiograph Software For Over-The-Counter Use”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230292

Official FDA database record

Date of final decision

May 2, 2023

Company on the FDA list

Samsung Electronics Co., Ltd

Lead panel

Cardiovascular

Primary product code

QDA

openFDA device name for the code

Electrocardiograph Software For Over-The-Counter Use

Device class

2

Regulation number

870.2345

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary