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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 interventional cardiovascular implant simulation software device
De Novo Number DEN200030
Device Name FEops HEARTguide
FEops NV
technologiepark 122
gent,  BE 9052
Contact sofie van cauter
Regulation Number870.1405
Classification Product Code
Date Received05/07/2020
Decision Date 09/08/2021
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct