OQU · Airway Monitoring System
Anesthesiology · 21 CFR 868.5730 · Class 2
Overview
| Product Code | OQU |
|---|---|
| Device Name | Airway Monitoring System |
| Regulation | 21 CFR 868.5730 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
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 | SonarMed AirWave Airway Monitoring System | Sonarmed, Inc. | May 15, 2020 | SESE |
| K143042 | SonarMed AirWave, Airway Monitoring System | Sonarmed, Inc. | Jan 22, 2016 | SESE |
| K092611 | SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 | Sonarmed, Inc. | Apr 28, 2010 | SESE |
Top Applicants
- Sonarmed, Inc. — 3 clearances
