ECG App

Electrocardiograph Software For Over-the-counter Use

Apple Inc.

The following data is part of a premarket notification filed by Apple Inc. with the FDA for Ecg App.

Pre-market Notification Details

Device IDK201525
510k NumberK201525
Device Name:ECG App
ClassificationElectrocardiograph Software For Over-the-counter Use
Applicant Apple Inc. One Apple Park Way Cupertino,  CA  94015
ContactLuke Olson
CorrespondentLuke Olson
Apple Inc. One Apple Park Way Cupertino,  CA  94015
Product CodeQDA  
CFR Regulation Number870.2345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-08
Decision Date2020-10-08

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