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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K143035
Device Name Flight 60 Ventilator
Applicant
Flight Medical Innovations , Ltd.
13 Hamelacha St.
North Industrial Park
Lod,  IL 71520
Applicant Contact Yanir Shaked
Correspondent
Mjrac
1208-12 Rockford Rd.
Toronto,  CA M2R 3A2
Correspondent Contact Bosmat Friedman
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
NOU  
Date Received10/22/2014
Decision Date 03/30/2016
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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