The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Matrix Mt-mx3.
| Device ID | K974700 |
| 510k Number | K974700 |
| Device Name: | MATRIX MT-MX3 |
| Classification | Accelerator, Linear, Medical |
| Applicant | MEDTEC, INC. 1401 8TH ST. S.E. P.O. BOX 602 Orange City, IA 51041 |
| Contact | Donald F Ribe |
| Correspondent | Donald F Ribe MEDTEC, INC. 1401 8TH ST. S.E. P.O. BOX 602 Orange City, IA 51041 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-16 |
| Decision Date | 1998-03-04 |