The following data is part of a premarket notification filed by Medical Graphics Corp. with the FDA for Medgraphics Pf/dx.
| Device ID | K912906 |
| 510k Number | K912906 |
| Device Name: | MEDGRAPHICS PF/DX |
| Classification | Computer, Oxygen-uptake |
| Applicant | MEDICAL GRAPHICS CORP. 350 OAK GROVE PKWY. St. Paul, MN 55127 -8599 |
| Contact | Dean Bruhn-dingndy |
| Correspondent | Dean Bruhn-dingndy MEDICAL GRAPHICS CORP. 350 OAK GROVE PKWY. St. Paul, MN 55127 -8599 |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-02 |
| Decision Date | 1992-02-04 |