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Electrocardiograph Software For Over-The-Counter Use

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Name
Company Name
Description
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KardiaMobile Card
Alivecor, Inc.
The AliveCor KardiaMobile Card System is a single-channel electrocardiogram (ECG) device that is intended to record, store, transfer, display, and analyze single-channel ECG rhythms.
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KardiaMobile 6L
Alivecor, Inc.
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Samsung ECG Monitor Application
Samsung Electronics Co., Ltd.
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Samsung ECG Monitor Application
Samsung Electronics Co., Ltd.
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Garmin ECG App
Garmin International, Inc.
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Garmin ECG App
Garmin International, Inc.
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Fitbit ECG App
FITBIT, INC.
The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AF detection function is not recommended for users with other known arrhythmias.The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG Spot Check isintended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old
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McKesson
MCKESSON MEDICAL-SURGICAL INC.
Glove, Exam Nitrile Blue CONFIDERM 6.8C PF X-Large 9” CUFF
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McKesson
MCKESSON MEDICAL-SURGICAL INC.
Glove, Exam Nitrile Blue CONFIDERM 6.8C PF Large 9” CUFF
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McKesson
MCKESSON MEDICAL-SURGICAL INC.
Glove, Exam Nitrile Blue CONFIDERM 6.8C PF Medium 9” CUFF
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McKesson
MCKESSON MEDICAL-SURGICAL INC.
Glove, Exam Nitrile Blue CONFIDERM 6.8C PF Small 9” CUFF
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McKesson
MCKESSON MEDICAL-SURGICAL INC.
Glove, Exam Nitrile Blue CONFIDERM 8.8C PF X-Large 12” CUFF
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McKesson
MCKESSON MEDICAL-SURGICAL INC.
Glove, Exam Nitrile Blue CONFIDERM 8.8C PF Large 12” CUFF
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McKesson
MCKESSON MEDICAL-SURGICAL INC.
Glove, Exam Nitrile Blue CONFIDERM 8.8C PF Medium 12” CUFF
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McKesson
MCKESSON MEDICAL-SURGICAL INC.
Glove, Exam Nitrile Blue CONFIDERM 8.8C PF Small 12” CUFF
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ECG 2.0 App
APPLE INC.
ECG iPhone App (version 2.0)
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ECG 2.0 App
APPLE INC.
ECG Watch App (version 2.0)
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ECG App
APPLE INC.
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ECG App
APPLE INC.
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Complete Blood Pressure Monitor +EKG
Omron Healthcare, Inc.
Blood Pressure Monitor and single channel EKG device.
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Samsung ECG Monitor App with Irregular Heart Rhythm Notification
Samsung Electronics Co., Ltd.
The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
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Samsung ECG Monitor App with Irregular Heart Rhythm Notification
Samsung Electronics Co., Ltd.
The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.