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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 K111683
Device Name FLIGHT 60 VENTILATOR
Applicant
FLIGHT MEDICAL INNOVATIONS LTD.
1914 JN PEASE PLACE
CHARLOTTE,  NC  28262
Applicant Contact SHOSHANA FRIEDMAN
Correspondent
FLIGHT MEDICAL INNOVATIONS LTD.
1914 JN PEASE PLACE
CHARLOTTE,  NC  28262
Correspondent Contact SHOSHANA FRIEDMAN
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
NOU  
Date Received06/15/2011
Decision Date 10/31/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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