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21 C.F.R. § 868.2500   Cutaneous oxygen (PcO₂) monitor.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart C—Monitoring Devices

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§ 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 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.

[67 FR 76681, Dec. 13, 2002]

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