FDA.reportPublic FDA data

De Novo DEN140017

Device
SENSIMED TRIGGERFISH
Contact
marcy moore
De Novo number
DEN140017
Product code
PLZ
Regulation
886.1925
Classification name
ocular pattern recorder
Decision
granted (DENG)
Decision date
2016-03-04
Date received
2014-05-06
Classification advisory
Ophthalmic
Review advisory
Ophthalmic
Type
Direct

Current FDA Classification#

Product code
PLZ
Device name
Ocular Pattern Recorder
Medical specialty
Ophthalmic
Device class
2
Regulation
886.1925
Implant
N
Life sustain/support
N