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

    Multi-Link X2 ECG Cable and Leadwire System

    K Number: K211294 · Decision Aug 16, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    101
    Applicant Total
    7
    Review Days
    110

    Basic Information

    Device Name
    Multi-Link X2 ECG Cable and Leadwire System
    K Number
    K211294
    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
    April 28, 2021
    Decision Date
    August 16, 2021
    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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