---
kind: "section"
citation: "21 C.F.R. § 868.2500"
title: "21"
number: "868.2500"
heading: "Cutaneous oxygen (PcO2) monitor."
url: "https://uscodex.org/cfr/21/868.2500"
---

# §868.2500. Cutaneous oxygen (PcO2) monitor.

- (a) **Identification.** A cutaneous oxygen (PcO2) monitor is a noninvasive, heated sensor (e.g., a Clark-type polargraphic electrode) placed on the patient's skin that is intended to monitor relative changes in the cutaneous oxygen tension.
- (b) **Classification.** Class II (special controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 868.9](/cfr/21/868.9.md). The special control 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

[67 FR 76681, Dec. 13, 2002, as amended at 84 FR 71811, Dec. 30, 2019]

### 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

[67 FR 76681, Dec. 13, 2002, as amended at 84 FR 71811, Dec. 30, 2019]