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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 (W/Wo Connector)
510(k) Number K152438
Device Name ETView VivaSight-SL (TVT) system
Applicant
Etview , Ltd.
M.P Misgav
Misgav Business Park,  IL 201790
Applicant Contact YORAM LEVY
Correspondent
Qsite
31 Haavoda St.
Binyamina,  IL 30500
Correspondent Contact YORAM LEVY
Regulation Number868.5730
Classification Product Code
BTR  
Date Received08/27/2015
Decision Date 02/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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