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