FDA.reportPublic FDA data

De Novo DEN200041

Device
Comfort Marker 2.0.
Contact
roland kortenhorst
De Novo number
DEN200041
Product code
QRN
Regulation
892.5785
Classification name
radiation therapy marking device
Decision
granted (DENG)
Decision date
2021-12-10
Date received
2020-06-22
Classification advisory
Radiology
Review advisory
Radiology
Type
Direct

Current FDA Classification#

Product code
QRN
Device name
Radiation Therapy Marking Device
Medical specialty
Radiology
Device class
2
Regulation
892.5785
Implant
N
Life sustain/support
N