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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
510(k) Number K133658
Device Name CDI BLOOD PARAMETER MONITORING SYSTEM 500
Applicant
Terumo Cardiovascular Systems Corp.
6200 Jackson Rd.
Ann Arbor,  MI  48103
Applicant Contact Kevin Kong
Correspondent
Terumo Cardiovascular Systems Corp.
6200 Jackson Rd.
Ann Arbor,  MI  48103
Correspondent Contact Kevin Kong
Regulation Number870.4330
Classification Product Code
DRY  
Date Received11/27/2013
Decision Date 07/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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