Code of Federal Regulations Title 21. Food and Drugs § 21.868.1200 Indwelling blood oxygen partial pressure (P O2 ) analyzer

(a) Identification. An indwelling blood oxygen partial pressure (P_O2) analyzer is a device that consists of a catheter-tip P_O2 transducer (e.g., P_O2 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.

(b) 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.”