MODIFIED GAS-STAT(TM) MONITORING SYSTEM
Device Facts
| Record ID | K864703 |
|---|---|
| Device Name | MODIFIED GAS-STAT(TM) MONITORING SYSTEM |
| Applicant | Cardiovascular Devices, Inc. |
| Product Code | DTY · Cardiovascular |
| Decision Date | Feb 19, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4410 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood.
