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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K051209
Device Name LEVITRONIX CENTRIMAG BACK-UP CONSOLE
Applicant
Levitronix, LLC
45 First Ave.
Waltham,  MA  02451
Applicant Contact FARZAD PARSAIE
Correspondent
Levitronix, LLC
45 First Ave.
Waltham,  MA  02451
Correspondent Contact FARZAD PARSAIE
Regulation Number870.4360
Classification Product Code
KFM  
Date Received05/11/2005
Decision Date 09/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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