FDA.reportPublic FDA data

De Novo DEN200076

Device
ORi
Contact
linus park
De Novo number
DEN200076
Product code
QWE
Regulation
870.2720
Classification name
hyperoxia monitoring device adjunct to pulse oximetry
Decision
granted (DENG)
Decision date
2023-10-12
Date received
2020-12-21
Classification advisory
Anesthesiology
Review advisory
Anesthesiology
Type
Direct

Current FDA Classification#

Product code
QWE
Device name
Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
Medical specialty
Anesthesiology
Device class
2
Regulation
870.2720
Implant
N
Life sustain/support
N