The following data is part of a premarket notification filed by Medicatech Usa with the FDA for Medicatech, Model Ddr Mak-800, Ddt Mak-1000 Fs, Ddr Mak-1100 Fa.
| Device ID | K080582 |
| 510k Number | K080582 |
| Device Name: | MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA |
| Classification | System, X-ray, Stationary |
| Applicant | MEDICATECH USA PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm MEDICATECH USA PO BOX 7007 Deerfield, IL 60015 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-03 |
| Decision Date | 2008-05-15 |
| Summary: | summary |