De Novo DEN210022

Device
PMD-200
Contact
rachel weissbrod
De Novo number
DEN210022
Product code
QVE
Regulation
868.2200
Classification name
adjunctive pain measurement device for anesthesiology
Decision
granted (DENG)
Decision date
2023-02-17
Date received
2021-06-04
Classification advisory
Anesthesiology
Review advisory
Anesthesiology
Type
Direct

Current FDA Classification#

Product code
QVE
Device name
Adjunctive Pain Measurement Device For Anesthesiology
Medical specialty
Anesthesiology
Device class
2
Regulation
868.2200
Implant
N
Life sustain/support
N