FDA.reportPublic FDA data

De Novo DEN230045

Device
Sonu
Contact
parameswaran gopi
De Novo number
DEN230045
Product code
QZC
Regulation
874.6010
Classification name
external mechanical stimulator for the relief of congestion
Decision
granted (DENG)
Decision date
2023-12-04
Date received
2023-06-16
Classification advisory
Ear Nose & Throat
Review advisory
Ear Nose & Throat
Type
Direct

Current FDA Classification#

Product code
QZC
Device name
External Mechanical Stimulator For The Relief Of Congestion
Medical specialty
Ear, Nose, Throat
Device class
2
Regulation
874.6010
Implant
N
Life sustain/support
N