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

    Multi-LinkTM X2 ECG Adapter and Leadwires

    K Number: K200510 · Decision Oct 9, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    9
    Review Days
    221

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    Basic Information

    Device Name
    Multi-LinkTM X2 ECG Adapter and Leadwires
    K Number
    K200510
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vyaire Medical, Inc.
    Date Received
    March 2, 2020
    Decision Date
    October 9, 2020
    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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