MODIFIED SARNS MEMBRANE OXYGENATOR
Device Facts
| Record ID | K863902 |
|---|---|
| Device Name | MODIFIED SARNS MEMBRANE OXYGENATOR |
| Applicant | 3M Health Care, Sarns |
| Product Code | DTX · Cardiovascular |
| Decision Date | Dec 11, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass gas control unit is a device used to control and measure the flow of gas into the oxygenator. The device is calibrated for a specific gas.
