21 CFR 868.2500

§ 868.2500 Cutaneous oxygen (PcO2) monitor.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 868.2500, § 868.2500 Cutaneous oxygen (PcO2) monitor, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89759
Permanent ID: ys:prov:89759@1
SHA-256: da112d8ef4ecd326044f98f84f20229199cee3a3f958570b5deae1cb6dd54b37

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Full text

(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 of this chapter subject to the limitations in § 868.9. 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) for the availability of this guidance document.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.