BIO PACK MODEL 200
Device Facts
| Record ID | K853126 |
|---|---|
| Device Name | BIO PACK MODEL 200 |
| Applicant | Bio Medicus, Inc. |
| Product Code | DWA · Cardiovascular |
| Decision Date | Oct 11, 1985 |
| 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.
