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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name electrocardiograph software for over-the-counter use
De Novo Number DEN180044
Device Name ECG App
Apple Inc
c/o biologics consulting group
400 n washington st., suite 100
alexandria,  VA  22314
Contact donna-bea tillman
Regulation Number870.2345
Classification Product Code
Date Received08/14/2018
Decision Date 09/11/2018
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct