The following data is part of a premarket notification filed by Minxray, Inc with the FDA for Cmdr 2c (multiple Models).
| Device ID | K201575 |
| 510k Number | K201575 |
| Device Name: | CMDR 2C (Multiple Models) |
| Classification | System, X-ray, Mobile |
| Applicant | MinXray, Inc 3611 Commercial Ave Northbrook, IL 60062 |
| Contact | Keith Kretchmer |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | IZL |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-11 |
| Decision Date | 2020-07-08 |