The following data is part of a premarket notification filed by Carbon Medical Technologies with the FDA for Biomarc Fiducial Marker.
| Device ID | K191797 |
| 510k Number | K191797 |
| Device Name: | BiomarC Fiducial Marker |
| Classification | Accelerator, Linear, Medical |
| Applicant | Carbon Medical Technologies 1290 Hammond Rd. St. Paul, MN 55110 -5876 |
| Contact | Eric Furlich |
| Correspondent | Eric Furlich Carbon Medical Technologies 1290 Hammond Rd. St. Paul, MN 55110 -5876 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-03 |
| Decision Date | 2019-07-29 |
| Summary: | summary |