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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
Original Applicant
FLIGHT MEDICAL INNOVATIONS LTD.
1914 jn pease place
charlotte,  NC  28262
Original 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 (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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