De Novo DEN110002

Device
SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT
Contact
robert sullivan
De Novo number
DEN110002
Product code
OVY
Regulation
880.6887
Classification name
liquid chemical processing system
Decision
granted (DENG)
Decision date
2012-03-30
Date received
2011-08-01
Classification advisory
General Hospital
Review advisory
General Hospital
Type
Post-NSE

Current FDA Classification#

Product code
OVY
Device name
Liquid Chemical Processing System
Medical specialty
General Hospital
Device class
2
Regulation
880.6887
Implant
N
Life sustain/support
N