GEM-6, WITH COMPONENTS
Device Facts
| Record ID | K854357 |
|---|---|
| Device Name | GEM-6, WITH COMPONENTS |
| Applicant | Diamond Electro-Tech, Inc. |
| Product Code | DRY · Cardiovascular |
| Decision Date | Jan 8, 1986 |
| 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.
