The following data is part of a premarket notification filed by Oxos Medical, Inc. with the FDA for Micro C Medical Imaging System, M01.
| Device ID | K211473 |
| 510k Number | K211473 |
| Device Name: | Micro C Medical Imaging System, M01 |
| Classification | System, X-ray, Mobile |
| Applicant | OXOS Medical, Inc. 1230 Peachtree Street NE Suite 300 Atlanta, GA 30309 |
| Contact | Evan Ruff |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-05-12 |
| Decision Date | 2021-06-04 |