STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE
Device Facts
| Record ID | K950990 |
|---|---|
| Device Name | STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE |
| Applicant | Stoeckert Instrumente |
| Product Code | DTQ · Cardiovascular |
| Decision Date | Jan 19, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4220 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.
