The following data is part of a premarket notification filed by Medical Graphics Corp. with the FDA for Cpx, Ccm, Cath With 15% Co2.
| Device ID | K955432 |
| 510k Number | K955432 |
| Device Name: | CPX, CCM, CATH WITH 15% CO2 |
| Classification | Calculator, Pulmonary Function Interpretor (diagnostic) |
| Applicant | MEDICAL GRAPHICS CORP. 350 OAK GROVE PKWY. St. Paul, MN 55127 -8599 |
| Contact | Michael G Snow |
| Correspondent | Michael G Snow MEDICAL GRAPHICS CORP. 350 OAK GROVE PKWY. St. Paul, MN 55127 -8599 |
| Product Code | BZM |
| CFR Regulation Number | 868.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-28 |
| Decision Date | 1996-07-01 |