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510(k) K193058

SonarMed AirWave Airway Monitoring System by Sonarmed, Inc. — Product Code OQU

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 15, 2020
Date Received: November 1, 2019
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Airway Monitoring System
Device Class: Class II
Regulation Number: 868.5730
Review Panel: AN
Submission Type

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