The following data is part of a premarket notification filed by Medtronic Bio-medicus, Inc. with the FDA for Medtronic Bio-medicus Bio-console Model 550.
| Device ID | K924205 |
| 510k Number | K924205 |
| Device Name: | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550 |
| Classification | Control, Pump Speed, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie, MN 55344 |
| Contact | Thomas K Johnsen |
| Correspondent | Thomas K Johnsen MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH 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 | 1992-08-20 |
| Decision Date | 1993-05-06 |