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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 K092611
Device Name SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901
Applicant
SONARMED, INC.
5513 WEST 74TH ST.
INDIANAPOLIS,  IN  46268
Applicant Contact LAURA LYONS
Correspondent
SONARMED, INC.
5513 WEST 74TH ST.
INDIANAPOLIS,  IN  46268
Correspondent Contact LAURA LYONS
Regulation Number868.5730
Classification Product Code
OQU  
Date Received08/26/2009
Decision Date 04/28/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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