The following data is part of a premarket notification filed by Xri, Inc. with the FDA for Mpr-814.
| Device ID | K940442 |
| 510k Number | K940442 |
| Device Name: | MPR-814 |
| Classification | Tube Mount, X-ray, Diagnostic |
| Applicant | XRI, INC. 2882-A WALNUT AVE. Tustin, CA 92680 |
| Contact | Robert Doubledee |
| Correspondent | Robert Doubledee XRI, INC. 2882-A WALNUT AVE. Tustin, CA 92680 |
| Product Code | IYB |
| CFR Regulation Number | 892.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-01 |
| Decision Date | 1994-06-09 |