POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM
Device Facts
| Record ID | K951094 |
|---|---|
| Device Name | POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM |
| Applicant | Optical Sensors, Inc. |
| Product Code | CCC · Anesthesiology |
| Decision Date | Jan 16, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1150 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An indwelling blood carbon dioxide partial pressure PCO2 analyzer is a device that consists of a catheter-tip PCO2 transducer (e.g., PCO2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide 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.”
