De Novo DEN170072

Device
Enlight 1810
Contact
rafael holzhacker
De Novo number
DEN170072
Product code
QEB
Regulation
868.1505
Classification name
ventilatory electrical impedance tomograph
Decision
granted (DENG)
Decision date
2018-12-20
Date received
2017-09-29
Classification advisory
Anesthesiology
Review advisory
Anesthesiology
Type
Direct

Current FDA Classification#

Product code
QEB
Device name
Ventilatory Electrical Impedance Tomograph
Medical specialty
Anesthesiology
Device class
2
Regulation
868.1505
Implant
N
Life sustain/support
N