FDA Product Code
FDA Product Code QRN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5785
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K222112 | Comfort Marker 2.0 | Medical Precision BV | 2023-03-30 | Traditional | PDF ↗ |
| DEN200041 | Comfort Marker 2.0. | Medical Precision BV | 2021-12-10 | Direct | — |
Product code QRN · Class II · Radiology. Data: openFDA.