510(k) DEN200041
- Device
- Comfort Marker 2.0.
- Applicant
- Medical Precision BV
- 510(k) number
- DEN200041
- Product code
- QRN
- Decision
- Unknown (DENG)
- Decision date
- 2021-12-10
- Date received
- 2020-06-22
- Regulation
- 892.5785
- Classification name
- Radiation Therapy Marking Device
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Roland Kortenhorst
- Address
- Telfordstraat 9 - 30 Zwolle NL 8013 RL 8013 RL
FDA Registration Numbers#
- 3008574006
- 3010163695
- 3021371724
- 3008388260
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QRN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222112 | Comfort Marker 2.0 | Medical Precision BV | 2023-03-30 |