The following data is part of a premarket notification filed by Mrx-ray Tube Corp. with the FDA for Mrx-865.
| Device ID | K921130 |
| 510k Number | K921130 |
| Device Name: | MRX-865 |
| Classification | Assembly, Tube Housing, X-ray, Diagnostic |
| Applicant | MRX-RAY TUBE CORP. 320 WESTWAY PL. SUITE 520 Arlington, TX 76018 |
| Contact | Richard B Bell |
| Correspondent | Richard B Bell MRX-RAY TUBE CORP. 320 WESTWAY PL. SUITE 520 Arlington, TX 76018 |
| Product Code | ITY |
| CFR Regulation Number | 892.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-10 |
| Decision Date | 1992-09-10 |