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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 K101643
Device Name MODEL LTV 1100 VENTILATOR
Applicant
CAREFUSION
75 NORTH FAIRWAY DRIVE
VERNON HILLS,  IL  60061
Applicant Contact MONTHER ABUSHABAN
Correspondent
CAREFUSION
75 NORTH FAIRWAY DRIVE
VERNON HILLS,  IL  60061
Correspondent Contact MONTHER ABUSHABAN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/10/2010
Decision Date 01/26/2011
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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