The following data is part of a premarket notification filed by Medical Graphics Corp. with the FDA for Mgc/litton 2300.
| Device ID | K820475 |
| 510k Number | K820475 |
| Device Name: | MGC/LITTON 2300 |
| Classification | Computer, Oxygen-uptake |
| Applicant | MEDICAL GRAPHICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-19 |
| Decision Date | 1982-03-23 |