FDA.reportPublic FDA data

De Novo DEN170001

Device
Precision Flow® HVNI
Contact
som kovvuri
De Novo number
DEN170001
Product code
QAV
Regulation
868.5454
Classification name
high flow/high velocity humidified oxygen delivery device
Decision
granted (DENG)
Decision date
2018-04-10
Date received
2017-01-03
Classification advisory
Anesthesiology
Review advisory
Anesthesiology
Type
Direct

Current FDA Classification#

Product code
QAV
Device name
High Flow/High Velocity Humidified Oxygen Delivery Device
Medical specialty
Anesthesiology
Device class
2
Regulation
868.5454
Implant
N
Life sustain/support
N