← Product Code [LKD](/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD) · K905225

# HBO CABLE ASSEMBLY, RADIOMETER TC-02 (K905225)

_Sechrist · LKD · Apr 10, 1991 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-c%E2%80%94monitoring-devices/LKD/K905225

## Device Facts

- **Applicant:** Sechrist
- **Product Code:** [LKD](/submissions/AN/subpart-c%E2%80%94monitoring-devices/LKD.md)
- **Decision Date:** Apr 10, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.2480
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-c%E2%80%94monitoring-devices/LKD/K905225](https://fda.innolitics.com/submissions/RA/subpart-c%E2%80%94monitoring-devices/LKD/K905225)

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