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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K140181
Device Name MEDOS HILITE INFANT OXYGENATOR
Applicant
Medos Medizintechnik AG
3526 W. Liberty Rd.
Ann Arbor,  MI  48103
Applicant Contact Leann Christman
Correspondent
Medos Medizintechnik AG
3526 W. Liberty Rd.
Ann Arbor,  MI  48103
Correspondent Contact Leann Christman
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received01/24/2014
Decision Date 02/19/2014
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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