Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1400](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1400) → OGK — Orotracheal Intubation Guide Kit

# OGK · Orotracheal Intubation Guide Kit

_Anesthesiology · 21 CFR 868.1400 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/OGK

## Overview

- **Product Code:** OGK
- **Device Name:** Orotracheal Intubation Guide Kit
- **Regulation:** [21 CFR 868.1400](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1400)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/OGK](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/OGK)

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