MONITOR, SENSOMATIII OXYGEN
Device Facts
| Record ID | K781910 |
|---|---|
| Device Name | MONITOR, SENSOMATIII OXYGEN |
| Applicant | Biochem International, Inc. |
| Product Code | KLK · Anesthesiology |
| Decision Date | Dec 26, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2500 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
