CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 868—ANESTHESIOLOGY DEVICES > SUBPART B—Diagnostic Devices (§868.1030 to §868.1975) > 868.1150—Indwelling blood carbon dioxide partial pressure (P CO2 ) analyzer.

868.1150—Indwelling blood carbon dioxide partial pressure (P CO2 ) analyzer.

(a) 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.
(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.”

Code of Federal Regulations

[47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 52 FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, 2001]