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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 K123853
Device Name VIVASIGHT-DL 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 Received12/14/2012
Decision Date 04/15/2013
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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