The following data is part of a premarket notification filed by Medical Graphics Corp. with the FDA for System 1085 Body Plethysmograph.
| Device ID | K852088 |
| 510k Number | K852088 |
| Device Name: | SYSTEM 1085 BODY PLETHYSMOGRAPH |
| Classification | Plethysmograph, Pressure |
| Applicant | MEDICAL GRAPHICS CORP. 501 WEST COUNTY RD. E St. Paul, MN 55112 |
| Contact | Ronald H Bergeson |
| Correspondent | Ronald H Bergeson MEDICAL GRAPHICS CORP. 501 WEST COUNTY RD. E St. Paul, MN 55112 |
| Product Code | CCM |
| CFR Regulation Number | 868.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-13 |
| Decision Date | 1985-07-30 |