LPP · Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
Anesthesiology · 21 CFR 868.2500 · Class 2
Overview
| Product Code | LPP |
|---|---|
| Device Name | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia |
| Regulation | 21 CFR 868.2500 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
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.
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K001866 | TCM400 | Radiometer Medical A/S | Dec 7, 2000 | SESE |
| K885079 | HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275 | Mennen Medical, Inc. | Feb 17, 1989 | SESE |
Top Applicants
- Radiometer Medical A/S — 1 clearance
- Mennen Medical, Inc. — 1 clearance
