← Product Code [KLK](/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK) · K842497

# SERVOMED OXYMONITO SMK 363 (K842497)

_Litton Datamedix · KLK · Oct 4, 1984 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K842497

## Device Facts

- **Applicant:** Litton Datamedix
- **Product Code:** [KLK](/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK.md)
- **Decision Date:** Oct 4, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.2500
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K842497](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K842497)

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