FDA.reportPublic FDA data

De Novo DEN160044

Device
Acumen Hypotension Prediction Index (HPI) Feature Software
Contact
lisa gilman
De Novo number
DEN160044
Product code
QAQ
Regulation
870.2210
Classification name
adjunctive predictive cardiovascular indicator
Decision
granted (DENG)
Decision date
2018-03-16
Date received
2016-09-26
Classification advisory
Cardiovascular
Review advisory
Cardiovascular
Type
Direct

Current FDA Classification#

Product code
QAQ
Device name
Adjunctive Predictive Cardiovascular Indicator
Medical specialty
Cardiovascular
Device class
2
Regulation
870.2210
Implant
N
Life sustain/support
N