FDA.reportPublic FDA data

De Novo DEN030001

Device
NIOX ARTICLE NO: 02-1000
Contact
sean m curry
De Novo number
DEN030001
Product code
MXA
Regulation
862.3080
Classification name
system, test, breath nitric oxide
Decision
granted (DENG)
Decision date
2003-04-30
Date received
2003-03-18
Classification advisory
Toxicology
Review advisory
Toxicology
Type
Post-NSE

Current FDA Classification#

Product code
MXA
Device name
System, Test, Breath Nitric Oxide
Medical specialty
Clinical Toxicology
Device class
2
Regulation
862.3080
Implant
N
Life sustain/support
N