De Novo DEN140024

Device
cNEP Airway
Contact
richard rose
De Novo number
DEN140024
Product code
PMB
Regulation
868.5105
Classification name
external airway
Decision
granted (DENG)
Decision date
2015-12-23
Date received
2014-08-18
Classification advisory
Anesthesiology
Review advisory
Anesthesiology
Type
Direct

Current FDA Classification#

Product code
PMB
Device name
External Airway
Medical specialty
Anesthesiology
Device class
2
Regulation
868.5105
Implant
N
Life sustain/support
N