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OQU — Airway Monitoring System Class II

FDA Device Classification

Classification Details

Product Code
OQU
Device Class
Class II
Regulation Number
868.5730
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Definition

The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K193058sonarmedSonarMed AirWave Airway Monitoring SystemMay 15, 2020
K143042sonarmedSonarMed AirWave, Airway Monitoring SystemJanuary 22, 2016
K092611sonarmedSONARMED AIRWAY MONITORING SYSTEM, MODEL 0901April 28, 2010