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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 adjunctive open loop fluid therapy recommender
De Novo Number DEN190029
Device Name Acumen Assisted Fluid Management (AFM) Software Feature
Requester
edwards lifesciences
one edwards way
irvine,  CA  92614
Contact lisa gilman
Regulation Number870.5600
Classification Product Code
QMS  
Date Received06/03/2019
Decision Date 11/13/2020
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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