The following data is part of a premarket notification filed by Medtronic Bio-medicus, Inc. with the FDA for Bio-medicus Bio-console Models 540, 540a,b,c,d,e, & 550.
| Device ID | K941921 |
| 510k Number | K941921 |
| Device Name: | BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 |
| Classification | Control, Pump Speed, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie, MN 55344 |
| Contact | Thomas Johnsen |
| Correspondent | Thomas 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 | 1994-04-20 |
| Decision Date | 1994-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994115799 | K941921 | 000 |
| 00681490408424 | K941921 | 000 |
| 00681490408400 | K941921 | 000 |
| 00673978877235 | K941921 | 000 |
| 00673978170114 | K941921 | 000 |
| 00673978169675 | K941921 | 000 |
| 00673978166025 | K941921 | 000 |