SATURATION/HEMATOCRIT MONITOR SYSTEM
Device Facts
| Record ID | K910421 |
|---|---|
| Device Name | SATURATION/HEMATOCRIT MONITOR SYSTEM |
| Applicant | Medtronic Vascular |
| Product Code | DRY · Cardiovascular |
| Decision Date | Oct 15, 1991 |
| 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.
