The following data is part of a premarket notification filed by Med-tec,inc. with the FDA for Pro Series Couch Software, Model Mt-pro100.
| Device ID | K034054 |
| 510k Number | K034054 |
| Device Name: | PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 |
| Classification | Couch, Radiation Therapy, Powered |
| 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 | JAI |
| CFR Regulation Number | 892.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-30 |
| Decision Date | 2004-02-20 |