BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System

    K Number: K163316 · Decision Jun 22, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    7
    Review Days
    211

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    Basic Information

    Device Name
    Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System
    K Number
    K163316
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carefusion 303, Inc.
    Date Received
    November 23, 2016
    Decision Date
    June 22, 2017
    Product Code
    DSA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DSA Cable, Transducer And Electrode, Patient, (Including Connector)

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