FDA.reportPublic FDA data

De Novo DEN120011

Device
PROTEUS INGESTION CONFINMATION SYSTEMS
Contact
jafar shenasa
De Novo number
DEN120011
Product code
OZW
Regulation
880.6305
Classification name
ingestible event marker
Decision
granted (DENG)
Decision date
2012-07-10
Date received
2012-05-11
Classification advisory
General Hospital
Review advisory
Gastroenterology/Urology
Type
Post-NSE

Current FDA Classification#

Product code
OZW
Device name
Ingestible Event Marker
Medical specialty
General Hospital
Device class
2
Regulation
880.6305
Implant
N
Life sustain/support
N