510(k) K221774

Garmin ECG App by Garmin International, Inc. — Product Code QDA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 12, 2023
Date Received: June 21, 2022
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Electrocardiograph Software For Over-The-Counter Use
Device Class: Class II
Regulation Number: 870.2345
Review Panel: CV
Submission Type

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.

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