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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 photoplethysmograph analysis software for over-the-counter use
De Novo Number DEN180042
Device Name Irregular Rhythm Notification Feature
Requester
apple, inc.
alexandria,  VA  22314
Contact donna-bea tillman
Regulation Number870.2790
Classification Product Code
QDB  
Date Received08/09/2018
Decision Date 09/11/2018
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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