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 |