510(k) DEN180044

ECG App by Apple, Inc. — Product Code QDA

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: September 11, 2018
Date Received: August 14, 2018
Clearance Type: Direct
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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Other clearances for product code QDA

K240795 — Withings ECG App (June 15, 2025)
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K230292 — Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (May 2, 2023)
K221774 — Garmin ECG App (January 12, 2023)
K201525 — ECG App (October 8, 2020)
K200948 — Fitbit ECG App (September 11, 2020)
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