GAS-STAT MONITORING SYSTEM
Device Facts
| Record ID | K831225 |
|---|---|
| Device Name | GAS-STAT MONITORING SYSTEM |
| Applicant | Cardiovascular Devices, Inc. |
| Product Code | DRY · Cardiovascular |
| Decision Date | May 27, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4330 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.