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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K132139
Device Name DELTEX MEDICAL CARDIOQ-EDM+
Applicant
Deltex Medical Limited
11440 W. Bernardo Ct.
Suite 300
San Diego,  CA  92127
Applicant Contact RONALD S WARREN
Correspondent
Deltex Medical Limited
11440 W. Bernardo Ct.
Suite 300
San Diego,  CA  92127
Correspondent Contact RONALD S WARREN
Regulation Number870.2100
Classification Product Code
DPW  
Date Received07/11/2013
Decision Date 10/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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