The following data is part of a premarket notification filed by Bio Medicus, Inc. with the FDA for Bio Medicus Bio Console 540.
| Device ID | K854133 |
| 510k Number | K854133 |
| Device Name: | BIO MEDICUS BIO CONSOLE 540 |
| Classification | Control, Pump Speed, Cardiopulmonary Bypass |
| Applicant | BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
| Contact | John R Dalpee |
| Correspondent | John R Dalpee BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
| Product Code | DWA |
| CFR Regulation Number | 870.4380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-10 |
| Decision Date | 1986-01-08 |