---
kind: "section"
citation: "21 C.F.R. § 868.2480"
title: "21"
number: "868.2480"
heading: "Cutaneous carbon dioxide (PcCO2) monitor."
url: "https://uscodex.org/cfr/21/868.2480"
---

# §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)](/cfr/21/868.1.md?p=e) for the availability of this guidance document.

## Notes

### Amendments

[54 FR 27160, June 28, 1989, as amended at 67 FR 76681, Dec. 13, 2002]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 47 FR 31142, July 16, 1982, unless otherwise noted.

### Amendments

[54 FR 27160, June 28, 1989, as amended at 67 FR 76681, Dec. 13, 2002]