OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100
Device Facts
| Record ID | K860106 |
|---|---|
| Device Name | OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100 |
| Applicant | American Bentley |
| Product Code | CCE · Anesthesiology |
| Decision Date | Feb 26, 1986 |
| 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.”
