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510(k) K201525

Device
ECG App
Applicant
Apple Inc.
510(k) number
K201525
Product code
QDA  
Decision
Substantially Equivalent (SESE)
Decision date
2020-10-08
Date received
2020-06-08
Regulation
870.2345
Classification name
Electrocardiograph Software For Over-the-counter Use
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Luke Olson
Address
One Apple Park Way Cupertino CA US 94015 94015

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QDA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240795Withings ECG AppWithings2025-06-15
K243236WHOOP ECG (electrocardiogram) Feature (1.0)Whoop., Inc.2025-04-04
K240909Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.2024-08-02
K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd.2023-05-02
K221774Garmin ECG AppGarmin International, Inc.2023-01-12
K200948Fitbit ECG AppFitbit, Inc.2020-09-11
K201168ECG Monitor AppSamsung Electronics Co., Ltd.2020-08-04
DEN180044ECG AppApple, Inc.2018-09-11

Legacy Summary#

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FDA Review#

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