The following data is part of a premarket notification filed by Medicatech Usa with the FDA for Digital Diagnostic X-ray System, Models Mak 1500, Mak 2000 And Mak 3000.
| Device ID | K082798 |
| 510k Number | K082798 |
| Device Name: | DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-23 |
| Decision Date | 2008-10-28 |
| Summary: | summary |