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FDA 510(k)

ECG App

K-Number: K201525 · 2020-10-08

ApplicantApple, Inc.
Decision Date2020-10-08
Product CodeQDA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG App is a medical device manufactured by Apple, Inc.. It received FDA 510(k) clearance on 2020-10-08 under approval number K201525. The device is classified under product code QDA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG App?

ECG App is a medical device that received FDA 510(k) clearance on 2020-10-08. It is manufactured by Apple, Inc.. The 510(k) number is K201525.

When was ECG App approved by the FDA?

ECG App received FDA 510(k) clearance on 2020-10-08, under approval number K201525.

What company makes ECG App?

ECG App is manufactured by Apple, Inc..

What is the FDA product code for ECG App?

The FDA product code for ECG App is QDA.

Other Devices by Apple, Inc.

DEN180044ECG App DEN180042Irregular Rhythm Notification Feature K212516IRNF App K213971Atrial Fibrillation History Feature K231173Irregular Rhythm Notification Feature (IRNF) K242058Digital Prism Correction Feature (DPCF)

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Related Devices (Code: QDA)

DEN180044ECG AppApple, Inc. K200948Fitbit ECG AppFitbit, Inc. K201168ECG Monitor AppSamsung Electronics Co., Ltd. K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd. K221774Garmin ECG AppGarmin International, Inc. K240909Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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