APPLICARD (EKG)
Device Facts
| Record ID | K900459 |
|---|---|
| Device Name | APPLICARD (EKG) |
| Applicant | Medi-Globe Corp. |
| Product Code | DRY · Cardiovascular |
| Decision Date | Jul 31, 1990 |
| 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.
