21 CFR 868.2500 — Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Anesthesiology (AN) · Part 868 Subpart C—Monitoring Devices · § 868.2500
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 2 | 47 | |
| LPP | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia | 2 | 2 |
Special Controls
KLK — Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
*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.
eCFR
KLK — Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
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.
Ecfr Llm
LPP — Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
*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.
eCFR
