The following data is part of a premarket notification filed by Med-tec,inc. with the FDA for Med-tec (medical Intelligence) Bodyfix System, Model Mt-bfx.
| Device ID | K001052 |
| 510k Number | K001052 |
| Device Name: | MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX |
| Classification | Accelerator, Linear, Medical |
| Applicant | MED-TEC,INC. 1401 8TH ST. S.E. P.O. BOX 320 Orange City, IA 51041 |
| Contact | Donald F Riibe |
| Correspondent | Donald F Riibe MED-TEC,INC. 1401 8TH ST. S.E. P.O. BOX 320 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 | 2000-04-03 |
| Decision Date | 2000-08-30 |