FDA.reportPublic FDA data

De Novo DEN010002

Device
GIVEN DIAGNOSTIC IMAGING SYSTEM
Contact
shoshana friedman
De Novo number
DEN010002
Product code
NEZ
Regulation
876.1300
Classification name
system, imaging, gastrointestinal, wireless, capsule
Decision
granted (DENG)
Decision date
2001-08-01
Date received
2001-06-11
Classification advisory
Gastroenterology/Urology
Review advisory
Gastroenterology/Urology
Type
Post-NSE

Current FDA Classification#

Product code
NEZ
Device name
System, Imaging, Gastrointestinal, Wireless, Capsule
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation
876.1300
Implant
N
Life sustain/support
N