(a) Identification. A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH-sensitive glass electrode placed on a patient's skin, which is intended to monitor relative changes in a hemodynamically stable patient's cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement.
(b) Classification. Class II (special controls). The special control for this device is FDA's ``Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.'' See Sec. 868.1(e) for the availability of this guidance document. [54 FR 27160, June 28, 1989, as amended at 67 FR 76681, Dec. 13, 2002]