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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
510(k) Number K113576
Device Name DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM
Applicant
Etview , Ltd.
31 Haavoda St.
Binyamina,  IL 30500
Applicant Contact YORAM LEVY
Correspondent
Etview , Ltd.
31 Haavoda St.
Binyamina,  IL 30500
Correspondent Contact YORAM LEVY
Regulation Number868.5740
Classification Product Code
CBI  
Date Received12/05/2011
Decision Date 05/18/2012
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
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