GAS-FLOW METER GFL 10
Device Facts
| Record ID | K822820 |
|---|---|
| Device Name | GAS-FLOW METER GFL 10 |
| Applicant | Gambro, Inc. |
| Product Code | DTX · Cardiovascular |
| Decision Date | Oct 18, 1982 |
| 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.