De Novo DEN190029

Device: Acumen Assisted Fluid Management (AFM) Software Feature
Contact: lisa gilman
De Novo number: DEN190029
Product code: QMS
Regulation: 870.5600
Classification name: adjunctive open loop fluid therapy recommender
Decision: granted (DENG)
Decision date: 2020-11-13
Date received: 2019-06-03
Classification advisory: Cardiovascular
Review advisory: Cardiovascular
Type: Direct

Current FDA Classification#

Product code: QMS
Device name: Adjunctive Open Loop Fluid Therapy Recommender
Medical specialty: Cardiovascular
Device class: 2
Regulation: 870.5600
Implant: N
Life sustain/support: N