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 Number | 870.5600
|
Classification Product Code |
|
Date Received | 06/03/2019 |
Decision Date | 11/13/2020 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Cardiovascular
|
Review Advisory Committee |
Cardiovascular
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|