The following data is part of a premarket notification filed by Medical Graphics Corp. with the FDA for Medgraphics Exercise Consult.
| Device ID | K923209 |
| 510k Number | K923209 |
| Device Name: | MEDGRAPHICS EXERCISE CONSULT |
| Classification | Calculator, Pulmonary Function Interpretor (diagnostic) |
| Applicant | MEDICAL GRAPHICS CORP. 350 OAK GROVE PKWY. St. Paul, MN 55127 -8599 |
| Contact | Dean Bruhn-ding |
| Correspondent | Dean Bruhn-ding MEDICAL GRAPHICS CORP. 350 OAK GROVE PKWY. St. Paul, MN 55127 -8599 |
| Product Code | BZM |
| CFR Regulation Number | 868.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-01 |
| Decision Date | 1993-03-11 |