FDA-Device2015-02-25Class III
Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).
Alivecor SFO
Hazard
Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.
Sold states
Downloaded by Apple users - locations not shared by Apple.
Affected count
5600 active users with Alive ECG app for iOS .
Manufactured in
30 Maiden Ln, Suite 600, San Francisco, CA, United States
Products
Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1125-2015Don't want to check this manually?
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