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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K163316
Device Name Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System
Applicant
Carefusion 303, Inc.
75 N Fairway Dr.
Vernon Hills,  IL  60061
Applicant Contact Erika Fernandez
Correspondent
Carefusion 303, Inc.
75 N Fairway Dr.
Vernon Hills,  IL  60061
Correspondent Contact Erika Fernandez
Regulation Number870.2900
Classification Product Code
DSA  
Date Received11/23/2016
Decision Date 06/22/2017
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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