The following data is part of a premarket notification filed by Medical Graphics Corp. with the FDA for Respiratory Diagnostic Equipment Calibrator.
| Device ID | K853848 |
| 510k Number | K853848 |
| Device Name: | RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR |
| Classification | Calibrator, Volume, Gas |
| Applicant | MEDICAL GRAPHICS CORP. 501 WEST COUNTY RD. E St. Paul, MN 55112 |
| Contact | Ronald Bergeson |
| Correspondent | Ronald Bergeson MEDICAL GRAPHICS CORP. 501 WEST COUNTY RD. E St. Paul, MN 55112 |
| Product Code | BXW |
| CFR Regulation Number | 868.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-16 |
| Decision Date | 1985-12-05 |