The following data is part of a premarket notification filed by Carbon Medical Technologies Inc. with the FDA for Fiducial Marker.
| Device ID | K211590 |
| 510k Number | K211590 |
| Device Name: | Fiducial Marker |
| Classification | Accelerator, Linear, Medical |
| Applicant | Carbon Medical Technologies Inc. 1290 Hammond Road St. Paul, MN 55110 |
| Contact | Eric Furlich |
| Correspondent | Eric Furlich Carbon Medical Technologies Inc. 1290 Hammond Road St. Paul, MN 55110 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-24 |
| Decision Date | 2021-06-10 |