The following data is part of a premarket notification filed by Tecnomed, Inc. with the FDA for Techny Rex 3000 Mobile X-ray Unit.
| Device ID | K803103 |
| 510k Number | K803103 |
| Device Name: | TECHNY REX 3000 MOBILE X-RAY UNIT |
| Classification | System, X-ray, Mobile |
| Applicant | TECNOMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-09 |
| Decision Date | 1981-01-22 |