The following data is part of a premarket notification filed by Bio Medicus, Inc. with the FDA for Bio-medicus Bio Console Models 540 A B C.
| Device ID | K901584 |
| 510k Number | K901584 |
| Device Name: | BIO-MEDICUS BIO CONSOLE MODELS 540 A B C |
| Classification | Control, Pump Speed, Cardiopulmonary Bypass |
| Applicant | BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
| Contact | Thomas K Johnsen |
| Correspondent | Thomas K Johnsen 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 | 1990-04-04 |
| Decision Date | 1990-06-28 |