Airway Monitoring System
The Airway Monitoring System (product code OQU) is an anesthesiology device intended to assist in verifying endotracheal tube (ETT) placement, detecting ETT tube movement, and identifying obstruction of the tube tip. It provides continuous monitoring of airway status during procedures requiring intubation. As an FDA Class 2 device under regulation 868.5730, it requires 510(k) premarket clearance and falls within the Anesthesiology medical specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OQU
- Device Class
- FDA class 2
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
Definition
The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K193058 | SonarMed AirWave Airway Monitoring System | May 15, 2020 | Substantially Equivalent | Sonarmed, Inc. |
| K143042 | SonarMed AirWave, Airway Monitoring System | Jan 22, 2016 | Substantially Equivalent | Sonarmed, Inc. |
| K092611 | SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 | Apr 28, 2010 | Substantially Equivalent | Sonarmed, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.