510(k) K222112
- Device
- Comfort Marker 2.0
- Applicant
- Medical Precision BV
- 510(k) number
- K222112
- Product code
- QRN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-30
- Date received
- 2022-07-18
- Regulation
- 892.5785
- Classification name
- Radiation Therapy Marking Device
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Blerta Kukaj
- Address
- Telfordstraat 9-30 Zwolle NL NL 8013 RL NL 8013 RL
FDA Registration Numbers
- 3008574006
- 3010163695
- 3008388260
- 3021371724
Source Documents
Other 510(k) Records For Product Code QRN
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN200041 | Comfort Marker 2.0. | Medical Precision BV | 2021-12-10 |