FDA.reportPublic FDA data

De Novo DEN990005

Device
THE 3PM EGG MACHINE
Contact
daniel j manelli
De Novo number
DEN990005
Product code
MYE
Regulation
876.1735
Classification name
system, electrogastrography (egg)
Decision
granted (DENG)
Decision date
1999-08-20
Date received
1999-07-12
Classification advisory
Gastroenterology/Urology
Review advisory
Gastroenterology/Urology
Type
Post-NSE

Current FDA Classification#

Product code
MYE
Device name
System, Electrogastrography (Egg)
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation
876.1735
Implant
N
Life sustain/support
N