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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airway Monitoring System
510(k) Number K193058
Device Name SonarMed AirWave Airway Monitoring System
Applicant
Sonarmed, Inc.
12220 N. Meridian St., Suite 150
Carmel,  IN  46032
Applicant Contact Laura Lyons
Correspondent
Sonarmed, Inc.
12220 N. Meridian St., Suite 150
Carmel,  IN  46032
Correspondent Contact Laura Lyons
Regulation Number868.5730
Classification Product Code
OQU  
Date Received11/01/2019
Decision Date 05/15/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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