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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 K181880
Device Name VivaSight-SL (TVT) system
Applicant
ETView Ltd.
M.P Misgav
Misgav Business Park,  IL 2017900
Applicant Contact Yoram Levy
Correspondent
Qsite
31 Haavoda St.
Binyamina,  IL 30500
Correspondent Contact Yoram Levy
Regulation Number868.5730
Classification Product Code
BTR  
Date Received07/13/2018
Decision Date 11/29/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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