The following data is part of a premarket notification filed by Medical Graphics Corp. with the FDA for Cardio-pulmonary Exercise Stress System.
| Device ID | K801495 |
| 510k Number | K801495 |
| Device Name: | CARDIO-PULMONARY EXERCISE STRESS SYSTEM |
| Classification | Calculator, Pulmonary Function Interpretor (diagnostic) |
| Applicant | MEDICAL GRAPHICS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BZM |
| CFR Regulation Number | 868.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-26 |
| Decision Date | 1980-07-21 |