The following data is part of a premarket notification filed by Medical Graphics Corp. with the FDA for System 5000.
| Device ID | K833756 |
| 510k Number | K833756 |
| Device Name: | SYSTEM 5000 |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | MEDICAL GRAPHICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-26 |
| Decision Date | 1984-04-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SYSTEM 5000 78248399 not registered Dead/Abandoned |
ConMed Corporation 2003-05-12 |
![]() SYSTEM 5000 75103494 not registered Dead/Abandoned |
DIGITAL CITY, INC. 1996-05-13 |
![]() SYSTEM 5000 73691471 1494047 Dead/Cancelled |
BALLY MANUFACTURING CORPORATION 1987-10-23 |
![]() SYSTEM 5000 73073450 1056902 Dead/Cancelled |
TRW Inc. 1976-01-05 |