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510(k) K092611

SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 by Sonarmed, Inc. — Product Code OQU

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 28, 2010
Date Received: August 26, 2009
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