Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5730](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5730) → OQU — Airway Monitoring System

# OQU · Airway Monitoring System

_Anesthesiology · 21 CFR 868.5730 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/OQU

## Overview

- **Product Code:** OQU
- **Device Name:** Airway Monitoring System
- **Regulation:** [21 CFR 868.5730](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5730)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K193058](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/OQU/K193058.md) | SonarMed AirWave Airway Monitoring System | Sonarmed, Inc. | May 15, 2020 | SESE |
| [K143042](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/OQU/K143042.md) | SonarMed AirWave, Airway Monitoring System | Sonarmed, Inc. | Jan 22, 2016 | SESE |
| [K092611](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/OQU/K092611.md) | SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 | Sonarmed, Inc. | Apr 28, 2010 | SESE |

## Top Applicants

- Sonarmed, Inc. — 3 clearances

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/OQU](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/OQU)

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