E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.
Device Facts
| Record ID | K900333 |
|---|---|
| Device Name | E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT. |
| Applicant | Radiometer America, Inc. |
| Product Code | LKD · Anesthesiology |
| Decision Date | Apr 16, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2480 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
