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510(k) K163316

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System by Carefusion 303, Inc. — Product Code DSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2017
Date Received
November 23, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type

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