The following data is part of a premarket notification filed by Medical Graphics Corp. with the FDA for Cpe 2000 Cardio Pulmonary Ergometer.
| Device ID | K874925 |
| 510k Number | K874925 |
| Device Name: | CPE 2000 CARDIO PULMONARY ERGOMETER |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| 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 | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-02 |
| Decision Date | 1988-01-19 |