FDA.reportPublic FDA data

De Novo DEN170089

Device
Curve Positive Airway Pressure System
Contact
mary lou mooney
De Novo number
DEN170089
Product code
QBY
Regulation
868.5273
Classification name
positive airway pressure system
Decision
granted (DENG)
Decision date
2018-06-05
Date received
2017-12-14
Classification advisory
Anesthesiology
Review advisory
Anesthesiology
Type
Direct

Current FDA Classification#

Product code
QBY
Device name
Positive Airway Pressure System
Medical specialty
Anesthesiology
Device class
2
Regulation
868.5273
Implant
N
Life sustain/support
N