Home / 510(k) Clearances / K201168

510(k) K201168

ECG Monitor App by Samsung Electronics Co., Ltd. — Product Code QDA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2020
Date Received
May 1, 2020
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.

Other clearances by Samsung Electronics Co., Ltd.

  • K242651 — GM85 (October 1, 2024)
  • K242478 — GF85 (models GF85-3P, GF85-SP) (September 19, 2024)
  • K240909 — Samsung ECG App v 1.3 (ECG) (August 2, 2024)
  • DEN230041 — Sleep Apnea Feature (February 6, 2024)
  • K230292 — Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (May 2, 2023)
  • K222353 — GM85 (September 29, 2022)
  • K220175 — GM85 (April 21, 2022)
  • K213452 — GEMS-H (April 21, 2022)
  • K211139 — CUBE Air Purifier (November 26, 2021)
  • K201560 — Auto Lung Nodule Detection (August 31, 2021)

Other clearances for product code QDA

  • K240795 — Withings ECG App (June 15, 2025)
  • K243236 — WHOOP ECG (electrocardiogram) Feature (1.0) (April 4, 2025)
  • K240909 — Samsung ECG App v 1.3 (ECG) (August 2, 2024)
  • 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)
  • DEN180044 — ECG App (September 11, 2018)