BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM
Device Facts
| Record ID | K954501 |
|---|---|
| Device Name | BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM |
| Applicant | Medtronic Bio-Medicus, Inc. |
| Product Code | DTY · Cardiovascular |
| Decision Date | Jan 16, 1996 |
| 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.
