The following data is part of a premarket notification filed by Medical Graphics Corp. with the FDA for Spirometry Module.
| Device ID | K861486 |
| 510k Number | K861486 |
| Device Name: | SPIROMETRY MODULE |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | MEDICAL GRAPHICS CORP. 350 OAK GROVE PKWY. St. Paul, MN 55127 -8599 |
| Contact | Ronald H Bergeson |
| Correspondent | Ronald H Bergeson MEDICAL GRAPHICS CORP. 350 OAK GROVE PKWY. St. Paul, MN 55127 -8599 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-22 |
| Decision Date | 1986-05-19 |