NEW COBE SATURATION/HEMATOCRIT MONITOR
Device Facts
| Record ID | K904336 |
|---|---|
| Device Name | NEW COBE SATURATION/HEMATOCRIT MONITOR |
| Applicant | Cobe Laboratories, Inc. |
| Product Code | GKF · Hematology |
| Decision Date | Dec 27, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.5600 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
