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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 oscillometric-based, over-the-counter, atrial fibrillation notification feature
De Novo Number DEN230076
Device Name Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ))
Requester
omron healthcare, inc.
2895 greenspoint pkwy.
suite 100
hoffman estates,  IL  60169
Contact terri ingalls
Regulation Number870.1135
Classification Product Code
QXY  
Date Received11/13/2023
Decision Date 10/08/2024
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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