INTRAVASCULAR BLOOD GAS SYSTEM
Device Facts
| Record ID | K843912 |
|---|---|
| Device Name | INTRAVASCULAR BLOOD GAS SYSTEM |
| Applicant | Cardiovascular Devices, Inc. |
| Product Code | CCE · Anesthesiology |
| Decision Date | Jan 10, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1200 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An indwelling blood oxygen partial pressure (PO2 ) analyzer is a device that consists of a catheter-tip PO2 transducer (e.g., PO2 electrode) and that is used to measure, in vivo, the partial pressure of oxygen in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”
