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

    EWC: ECG II CABLE LEADWIRE SYSTEM

    K Number: K984263 · Decision Feb 2, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    2
    Review Days
    64

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    Basic Information

    Device Name
    EWC: ECG II CABLE LEADWIRE SYSTEM
    K Number
    K984263
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ewc
    Date Received
    November 30, 1998
    Decision Date
    February 2, 1999
    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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    Other Clearances by Ewc

    K Number Device Name
    K982817 EWC: ECG CABLE AND LEADWIRE SYSTEMS