The following data is part of a premarket notification filed by Medical Graphics Corp. with the FDA for Pft Screener (system 1100).
| Device ID | K812792 |
| 510k Number | K812792 |
| Device Name: | PFT SCREENER (SYSTEM 1100) |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | MEDICAL GRAPHICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-06 |
| Decision Date | 1981-11-27 |