SARNS 9000 HEART-LUNG CONSOLE
Device Facts
| Record ID | K871131 |
|---|---|
| Device Name | SARNS 9000 HEART-LUNG CONSOLE |
| Applicant | 3M Health Care, Sarns |
| Product Code | DTQ · Cardiovascular |
| Decision Date | May 21, 1987 |
| 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.
