Title 21

SECTION 868.2480

868.2480 Cutaneous carbon dioxide (PcCO2) monitor.

§ 868.2480 Cutaneous carbon dioxide (PcCO2) monitor.

(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 § 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]