MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550
Device Facts
| Record ID | K924205 |
|---|---|
| Device Name | MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550 |
| Applicant | Medtronic Bio-Medicus, Inc. |
| Product Code | DWA · Cardiovascular |
| Decision Date | May 6, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4380 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.
