The following data is part of a premarket notification filed by Minxray, Inc. with the FDA for Cmdr-2st & Cmdr-2slwt Digital Portable X-ray.
| Device ID | K141885 |
| 510k Number | K141885 |
| Device Name: | CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY |
| Classification | System, X-ray, Mobile |
| Applicant | MINXRAY, INC. 8870 RAVELLO COURT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm MINXRAY, INC. 8870 RAVELLO COURT 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 | 2014-07-11 |
| Decision Date | 2014-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861050000347 | K141885 | 000 |
| 00861050000330 | K141885 | 000 |
| 00858846007055 | K141885 | 000 |
| 00858846007048 | K141885 | 000 |
| 00858846007031 | K141885 | 000 |