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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 the device name listed in this FDA 510(k) record. The listed applicant is Apple, Inc.. It received FDA 510(k) clearance on 2020-10-08 under 510(k) 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. The listed applicant is Apple, Inc.. The 510(k) number is K201525.

When did ECG App receive FDA 510(k) clearance?

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

Who is the listed applicant for ECG App?

The FDA 510(k) record lists Apple, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG App?

The FDA product code for ECG App is QDA.

Other records listing Apple, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253582Medical Imaging Calibration Feature (MICF)K250507Hypertension Notification Feature (HTNF)K250143Digital Prism Correction Feature (DPCF)K242058Digital Prism Correction Feature (DPCF)K240929Sleep Apnea Notification Feature (SANF)K231173Irregular Rhythm Notification Feature (IRNF)

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Related Devices (Code: QDA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240795Withings ECG AppWithingsK243236WHOOP ECG (electrocardiogram) Feature (1.0)Whoop., Inc.K240909Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd.K221774Garmin ECG AppGarmin International, Inc.K200948Fitbit ECG AppFitbit, Inc.

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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