The following data is part of a premarket notification filed by Medical Graphics Corp. with the FDA for Pulmonary Function Test Laboratory, System 1070.
| Device ID | K861929 |
| 510k Number | K861929 |
| Device Name: | PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070 |
| Classification | Calculator, Pulmonary Function Interpretor (diagnostic) |
| 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 | BZM |
| CFR Regulation Number | 868.1900 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-20 |
| Decision Date | 1986-09-26 |