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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 K120726
Device Name FLIGHT 60 VENTILATOR
Applicant
Flight Medical Innovations , Ltd.
1914 J.N. Pease Place
Chalotte,  NC  28262
Applicant Contact CHOSHANA FRIEDMAN
Correspondent
Flight Medical Innovations , Ltd.
1914 J.N. Pease Place
Chalotte,  NC  28262
Correspondent Contact CHOSHANA FRIEDMAN
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
NOU  
Date Received03/09/2012
Decision Date 07/06/2012
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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